| PMA Number | Suppl. Type | Device Name | Applicant | Decision Date |
|---|---|---|---|---|
|
P010031
S873 |
30-Day Notice | Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria Quad MRI CRT-D, Cobalt |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
11/27/2024 |
|
P130026
S092 |
30-Day Notice | TactiCath Ablation Catheter, Sensor Enabled (TactiCath SE) |
St. Jude Medical | 11/27/2024 |
|
P180046
S093 |
30-Day Notice | Axonics Sacral Neuromodulation System |
Axonics Modulation Technologies, Inc. |
11/27/2024 |
|
P190006
S093 |
30-Day Notice | Axonics Sacral Neuromodulation System |
Axonics Modulation Technologies, Inc. |
11/27/2024 |
|
P220012
S035 |
30-Day Notice | Aurora EV ICD | Medtronic, Inc. | 11/27/2024 |
|
P220013
S015 |
30-Day Notice | TactiFlex Ablation Catheter, Sensor Enabled (TactiFlex SE) |
Abbott Medical | 11/27/2024 |
|
P980016
S907 |
30-Day Notice | Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
11/27/2024 |
|
P030053
S075 |
30-Day Notice | MENTOR MemoryGel Breast Implants | MENTOR CORP. | 11/26/2024 |
|
P060028
S053 |
30-Day Notice | MENTOR MemoryShape Breast Implants | MENTOR WORLDWIDE LLC | 11/26/2024 |
|
P110035
S073 |
30-Day Notice | EPIC SELF-EXPANDING NITINOL STENT SYSTEM |
Boston Scientific Corp. | 11/26/2024 |
|
P140028
S081 |
30-Day Notice | Innova Vascular Self Expanding Stent With Delivery System |
BOSTON SCIENTIFIC CORPORATION |
11/26/2024 |
|
P170008
S055 |
30-Day Notice | EluNIR Ridaforolimus Eluting Coronary Stent System |
Medinol, Ltd. | 11/26/2024 |
|
P180011
S063 |
30-Day Notice | Eluvia Drug-Eluting Vascular Stent System |
Boston Scientific Corp. | 11/26/2024 |
|
P230014
S002 |
Real-Time Process | Lumicell Direct Visualization System | Lumicell, Inc. | 11/26/2024 |
|
P930038
S105 |
30-Day Notice | ANGIO-SEAL VIP Vascular Closure Device |
TERUMO MEDICAL CORPORATION |
11/26/2024 |
|
P990075
S061 |
30-Day Notice | MENTOR Saline-Filled And SPECTRUM Breast Implants |
MENTOR WORLDWIDE LLC | 11/26/2024 |
|
N970003
S297 |
30-Day Notice | L100 ESSENTIO SR, L101 ESSENTIO DR, L121 ESSENTIO EL DR, L200 PROPONENT SR, L201 PROPONENT DR, L221 PROPONENT EL DR, L30 |
Boston Scientific Corp. | 11/25/2024 |
|
P010012
S588 |
30-Day Notice | G124 MOMENTUM CRT-D, G125 MOMENTUM CRT-D, G126 MOMENTUM CRT-D, G128 MOMENTUM, G138 MOMENTUM X4 CRT-D, G140 INOGEN CRT-D, |
Boston Scientific Corp. | 11/25/2024 |
|
P020045
S110 |
Real-Time Process | Nitron CryoConsole, Nitron Foot Switch |
Medtronic CryoCath LP | 11/25/2024 |
|
P030005
S243 |
30-Day Notice | U125 VALITUDE CRT-P, U128 VALITUDE X4 CRT-P, U225 VISIONIST CRT-P, U226 VISIONIST CRT-P, U228 VISIONIST X4 CRT-P |
GUIDANT CORP. | 11/25/2024 |
|
P030011
S092 |
Normal 180 Day Track No User Fee |
Total Artificial Heart | SYNCARDIA SYSTEMS, LLC | 11/25/2024 |
|
P080025
S307 |
30-Day Notice | InterStim Therapy System, Verify Evaluation System |
MEDTRONIC NEUROMODULATION |
11/25/2024 |
|
P100009
S069 |
30-Day Notice | MitraClip™ G4 Clip Delivery System, MitraClip™ NTR Clip Delivery System, MitraClip™ XTR Clip Delivery System |
Abbott Medical | 11/25/2024 |
|
P100044
S055 |
30-Day Notice | Propel® Contour Sinus Implant | INTERSECT ENT | 11/25/2024 |
|
P100047
S221 |
Normal 180 Day Track | HEARTWARE VENTRICULAR ASSIST SYSTEM | Medtronic | 11/25/2024 |
|
P110023
S053 |
30-Day Notice | EverFlex™ Self-Expanding Peripheral Stent System, EverFlex™ Self-expanding Peripheral Stent With Entrust™ Delivery Syste |
MEDTRONIC VASCULAR INC | 11/25/2024 |
|
P110042
S201 |
30-Day Notice | A209 SICD Gen 2, A219 SICD MRI | BOSTON SCIENTIFIC CORPORATION |
11/25/2024 |
|
P150012
S163 |
30-Day Notice | L110 ESSENTIO MRI SR, L111 ESSENTIO MRI DR, L131 ESSENTIO MRI EL DR, L210 PROPONENT, L211 PROPONENT, L231 PROPONENT, L31 |
BOSTONSCIENTIFIC | 11/25/2024 |
|
P150048
S085 |
30-Day Notice | MITRIS RESILIA Mitral Valve | EDWARDS LIFESCIENCES, LLC. |
11/25/2024 |
|
P180046
S092 |
Normal 180 Day Track | Axonics Sacral Neuromodulation System |
Axonics Modulation Technologies, Inc. |
11/25/2024 |
|
P190006
S092 |
Normal 180 Day Track | Axonics Sacral Neuromodulation System |
Axonics Modulation Technologies, Inc. |
11/25/2024 |
|
P200045
S005 |
Normal 180 Day Track No User Fee |
RelayPro Thoracic Stent-Graft System | Bolton Medical, Inc. | 11/25/2024 |
|
P230007
S008 |
30-Day Notice | TriClip™ G4 Clip Delivery System | Abbott Medical | 11/25/2024 |
|
P960040
S503 |
30-Day Notice | D010 INOGEN MINI ICD VR, D011 INOGEN MINI ICD VR, D012 INOGEN MINI ICD DR, D013 INOGEN MINI ICD DR, D020 DYNAGEN MINI IC |
BOSTON SCIENTIFIC | 11/25/2024 |
|
P970004
S412 |
30-Day Notice | InterStim Therapy System, Verify Evaluation System |
MEDTRONIC NEUROMODULATION |
11/25/2024 |
|
P010030
S188 |
30-Day Notice | LifeVest® Wearable Defibrillator | ZOLL MANUFACTURING CORPORATION |
11/24/2024 |
|
P010014
S105 |
Panel Track | Oxford™ Cementless Partial Knee System |
BIOMET MANUFACTURING CORP. |
11/22/2024 |
|
P010014
S107 |
Normal 180 Day Track No User Fee |
Oxford® Partial Knee System | BIOMET MANUFACTURING CORP. |
11/22/2024 |
|
P010031
S874 |
30-Day Notice | Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
11/22/2024 |
|
P010032
S217 |
Normal 180 Day Track | SCS EPG 2-Port Header (Model 3042) | Abbott Medical | 11/22/2024 |
|
P030053
S069 |
Normal 180 Day Track | MemoryGel® Ultra High Profile - Extended Range (UH-R) Breast Implants |
MENTOR CORP. | 11/22/2024 |
|
P030054
S428 |
30-Day Notice | Avant, Entrant, Gallant, Neutrino NxT, Quadra Assura, Unify, Unify Assura, Unify Quadra |
Abbott Medical | 11/22/2024 |
|
P040013
S032 |
30-Day Notice | GEM 21S | Lynch Biologics LLC | 11/22/2024 |
|
P110022
S031 |
Normal 180 Day Track | Elecsys Anti-HBc IgM And PreciControl Anti-HBc IgM |
ROCHE DIAGNOSTICS CORP. | 11/22/2024 |
|
P110031
S025 |
Normal 180 Day Track | Elecsys Anti-HBc IgM And PreciControl Anti-HBc IgM |
ROCHE DIAGNOSTICS CORP. | 11/22/2024 |
|
P130026
S091 |
30-Day Notice | TactiCath Ablation Catheter, Sensor Enabled |
St. Jude Medical | 11/22/2024 |
|
P140010
S086 |
30-Day Notice | IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter |
MEDTRONIC Inc. | 11/22/2024 |
|
P150035
S020 |
Normal 180 Day Track No User Fee |
Aveir Leadless Pacemaker- Right Atrial, Aveir Leadless Pacemaker- Right Ventricular, |
Abbott Medical | 11/22/2024 |
|
P160043
S085 |
30-Day Notice | RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM |
MEDTRONIC VASCULAR | 11/22/2024 |
|
P180032
S019 |
Real-Time Process | Cerene Cryotherapy Device | Channel Medsystems, Inc. | 11/22/2024 |
|
P190002
S032 |
Real-Time Process | Saluda Medical Evoke® SCS System | SALUDA MEDICAL PTY LTD | 11/22/2024 |
|
P190008
S035 |
30-Day Notice | IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter |
Medtronic Vascular Inc. | 11/22/2024 |
|
P220012
S036 |
30-Day Notice | Aurora EV ICD | Medtronic, Inc. | 11/22/2024 |
|
P220013
S014 |
30-Day Notice | TactiFlex Ablation Catheter, Sensor Enabled |
Abbott Medical | 11/22/2024 |
|
P230005
S001 |
Normal 180 Day Track No User Fee |
Motiva SmoothSilk Round Ergonomix Silicone Gel-Filled Breast Implants, Motiva SmoothSilk Round Silicone Gel-Filled Breas |
Motiva USA, LLC | 11/22/2024 |
|
P240013
S001 |
30-Day Notice | Sphere-9™ Mapping And Ablation Catheter, Catheter Extension Cable, Tubing Set |
Medtronic Inc. | 11/22/2024 |
|
P240013
S002 |
30-Day Notice | Affera Sphere-9 Mapping And Ablation Catheter |
Medtronic Inc. | 11/22/2024 |
|
P860004
S434 |
Special (Immediate Track) |
SynchroMed Infusion System, Ascenda Intrathecal Catheters |
MEDTRONIC Inc. | 11/22/2024 |
|
P890003
S470 |
Real-Time Process | OUS Vitatron Application Software | Medtronic, Inc. | 11/22/2024 |
|
P910023
S473 |
30-Day Notice | Avant, Entrant, Fortify, Fortify Assura, Gallant, Neutrino NxT |
Abbott Medical | 11/22/2024 |
|
P950020
S145 |
30-Day Notice | WOLVERINE™ Coronary Cutting Balloon® |
Boston Scientific Corp. | 11/22/2024 |
|
P980016
S908 |
30-Day Notice | Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
11/22/2024 |
|
P990034
S045 |
Special (Immediate Track) |
IsoMed Infusion System | MEDTRONIC Inc. | 11/22/2024 |
|
P010015
S552 |
30-Day Notice | Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola |
MEDTRONIC Inc. | 11/21/2024 |
|
P040044
S107 |
30-Day Notice | MynxGrip Vascular Closure Device (5F, 6F/7F), Mynx Control Vascular Closure Device (5F, 6F/7F) |
Cordis US Corporation | 11/21/2024 |
|
P910001
S123 |
Real-Time Process | Philips Laser System | SPECTRANETICS CORP. | 11/21/2024 |
|
P980035
S800 |
30-Day Notice | Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, |
MEDTRONIC Inc. | 11/21/2024 |
|
P010068
S073 |
30-Day Notice | EZ Steer NAV DS Bi-Directional Electrophysiology Catheter, NAVISTAR DS Electrophysiology Catheter |
BIOSENSE WEBSTER, INC. | 11/20/2024 |
|
P030031
S137 |
30-Day Notice | NAVISTAR RMT Thermocool Electrophysiology Catheter, EZ Steer Thermocool Nav Bi-Directional Electrophysiology Catheter, T |
BIOSENSE WEBSTER, INC. | 11/20/2024 |
|
P040036
S099 |
30-Day Notice | Thermocool SmartTouch Bi-Directional Navigation Catheter, Thermocool SmartTouch Uni-Directional Navigation Catheter |
BIOSENSE WEBSTER, INC. | 11/20/2024 |
|
P100021
S126 |
30-Day Notice | Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System |
Medtronic Vascular | 11/20/2024 |
|
P160035
S047 |
30-Day Notice | EXCOR® Pediatric Ventricular Assist Device |
Berlin Heart Inc. | 11/20/2024 |
|
P210027
S013 |
30-Day Notice | QDOT Micro Uni-Directional Navigation Catheter, QDOT Micro Bi-Directional Navigation Catheter |
Biosense Webster, Inc. | 11/20/2024 |
| P210030 | Original | Roadsaver/CASPER Carotid Stent Device |
MicroVention, Inc. | 11/20/2024 |
|
P220012
S034 |
Real-Time Process | Aurora EV ICD | Medtronic, Inc. | 11/20/2024 |
|
P990025
S073 |
30-Day Notice | NAVISTAR Electrophysiology Catheter, EZ Steer NAV Bi-Directional Electrophysiology Catheter, NAVISTAR RMT Electrophysiol |
BIOSENSE WEBSTER, INC. | 11/20/2024 |
|
P990071
S062 |
30-Day Notice | Theermocool SF NAV Bi-Directional Catheter |
BIOSENSE WEBSTER, INC. | 11/20/2024 |
|
P990081
S054 |
Panel Track | PATHWAY Anti-her-2/neu (4B5) Rabbit Monoclonal Primary Antibody |
VENTANA MEDICAL SYSTEMS, INC. |
11/20/2024 |
|
BP953200
S126 |
30-Day Notice | Apligraf | Organogenesis, Inc. | 11/20/2024 |
|
P050019
S042 |
Normal 180 Day Track No User Fee |
Carotid Wallstent Monorail Endoprosthesis |
Boston Scientific Corp. | 11/19/2024 |
|
P120016
S037 |
30-Day Notice | Cardiva VASCADE MVP XL Venous Vascular Closure System (VVCS) |
CARDIVA MEDICAL, INC. | 11/19/2024 |
|
P160054
S089 |
30-Day Notice | HeartMate 3™ Left Ventricular Assist System |
Abbott Medical | 11/19/2024 |
|
P160054
S091 |
Normal 180 Day Track | HeartMate 3 Left Ventricular Assist System |
Abbott Medical | 11/19/2024 |
|
P170023
S019 |
30-Day Notice | Bulkamid Urethral Bulking System | Axonics Modulation Technologies, Inc. |
11/19/2024 |
|
P010014
S108 |
30-Day Notice | Oxford Partial Knee System | BIOMET MANUFACTURING CORP. |
11/18/2024 |
|
P040043
S137 |
Normal 180 Day Track No User Fee |
Conformable Gore® TAG® Thoracic Endoprosthesis, GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System |
W. L. GORE & ASSOCIATES, INC. |
11/18/2024 |
|
P100040
S064 |
Normal 180 Day Track No User Fee |
Valiant Thoratic Stent Graft With Captivia Delivery System |
Medtronic Vascular | 11/18/2024 |
|
P160054
S090 |
30-Day Notice | HeartMate 3™ Left Ventricular Assist System |
Abbott Medical | 11/18/2024 |
|
P180031
S009 |
30-Day Notice | Neuroform Atlas Stent System | Stryker Neurovascular | 11/18/2024 |
|
P190015
S022 |
Real-Time Process | TREO® Abdominal Stent-Graft System | Bolton Medical Inc. | 11/18/2024 |
|
P200045
S014 |
Real-Time Process | RelayPro Thoracic Stent-Graft System | Bolton Medical, Inc. | 11/18/2024 |
|
P230023
S005 |
Normal 180 Day Track No User Fee |
GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis |
W.L. Gore & Associates, Inc. |
11/18/2024 |
|
P840001
S578 |
30-Day Notice | Restore, Itrel®, Synergy®, Intellis™, Vanta™ And Inceptiv™ Spinal Cord Stimulation Systems, Pisces™, Specify®, And Vectr |
MEDTRONIC NEUROMODULATION |
11/18/2024 |
|
P010068
S072 |
Normal 180 Day Track No User Fee |
Nmarq Catheter Interference Cable | BIOSENSE WEBSTER, INC. | 11/15/2024 |
|
P030028
S010 |
Normal 180 Day Track No User Fee |
Artisan Myopia | OPHTEC BV | 11/15/2024 |
|
P030031
S135 |
Normal 180 Day Track No User Fee |
Nmarq Catheter Interference Cable | BIOSENSE WEBSTER, INC. | 11/15/2024 |
|
P040036
S097 |
Normal 180 Day Track No User Fee |
Nmarq Catheter Interference Cable | BIOSENSE WEBSTER, INC. | 11/15/2024 |
|
P040044
S105 |
30-Day Notice | MynxGrip Vascular Closure Device (5F, 6F/7F), Mynx Control Vascular Closure Device (5F, 6F/7F), Mynx Control Venous Vasc |
Cordis US Corporation | 11/15/2024 |
|
P040044
S106 |
30-Day Notice | MYNXGRIP Vascular Closure Device (5F, 6F/7F), MYNX CONTROL Vascular Closure Device (5F, 6F/7F), MYNX CONTROL VENOUS Vasc |
Cordis US Corporation | 11/15/2024 |
|
P080011
S167 |
Normal 180 Day Track No User Fee |
Ethos AquaTech Evolve Monthly | CooperVision, Inc. | 11/15/2024 |
|
P100045
S078 |
Special (Immediate Track) |
CardioMEMS HF System | Abbott Medical | 11/15/2024 |
|
P160022
S039 |
30-Day Notice | R Series | ZOLL MEDICAL CORPORATION | 11/15/2024 |
|
P210027
S008 |
Normal 180 Day Track No User Fee |
TX Eco Extension Cable | Biosense Webster, Inc. | 11/15/2024 |
|
P240009
S001 |
30-Day Notice | Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilatation Balloon System With Integrated Embolic Protection |
Contego Medical Inc. | 11/15/2024 |
|
P240009
S002 |
30-Day Notice | Neuroguard IEP 3-in-1 Carotid Stent And Post-Dilation Balloon System With Integrated Embolic Protection |
Contego Medical Inc. | 11/15/2024 |
|
P890003
S469 |
Real-Time Process | Carelink SmartSync™ Platform Carelink SmartSync TM Common Application |
Medtronic, Inc. | 11/15/2024 |
|
P890057
S027 |
135 Review Track For 30-Day Notice |
3100 High Frequency Oscillating Ventilator (HFOV), Vyaire Model 31008 Oscillatory Ventilator |
Vyaire Medical Inc. | 11/15/2024 |
|
P950005
S087 |
Normal 180 Day Track No User Fee |
Nmarq Catheter Interference Cable | Biosense Webster, Inc | 11/15/2024 |
|
P970051
S231 |
30-Day Notice | Nucleus CI632 Cochlear Implant, Nucleus CI532 Cochlear Implant |
Cochlear Americas | 11/15/2024 |
|
P990025
S072 |
Normal 180 Day Track No User Fee |
Nmarq Catheter Interference Cable | BIOSENSE WEBSTER, INC. | 11/15/2024 |
|
P990071
S060 |
Normal 180 Day Track No User Fee |
Smartablate System Interface Cable | BIOSENSE WEBSTER, INC. | 11/15/2024 |
|
P010015
S545 |
Real-Time Process | CareLink SmartSync Percepta Serena Solara App |
MEDTRONIC Inc. | 11/14/2024 |
|
P010031
S867 |
Real-Time Process | CareLink SmartSync Claria Amplia Compia App, CareLink SmartSync Cobalt, Crome App, CareLink SmartSync Viva Brava Evera A |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
11/14/2024 |
|
P140002
S028 |
30-Day Notice | MISAGO RX Self-expanding Peripheral Stent System, R2P MISAGO RX Self-expanding Peripheral Stent System |
TERUMO MEDICAL CORPORATION |
11/14/2024 |
|
P140031
S180 |
30-Day Notice | SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve |
EDWARDS LIFESCIENCES, LLC. |
11/14/2024 |
|
P150005
S086 |
Real-Time Process | Blazer Open Irrigated Ablation Catheter, IntellaNav Open Irrigated Ablation Catheter, IntellaNav MiFi Open Irrigated Abl |
Boston Scientific Corp. | 11/14/2024 |
|
P150033
S191 |
Real-Time Process | CareLink SmartSync Micra AV App, CareLink SmartSync Micra Evolution App, CareLink SmartSync Micra VR App |
MEDTRONIC Inc. | 11/14/2024 |
|
P150048
S084 |
30-Day Notice | INSPIRIS RESILIA Aortic Valve, MITRIS RESILIA Mitral Valve |
EDWARDS LIFESCIENCES, LLC. |
11/14/2024 |
|
P160054
S088 |
30-Day Notice | HeartMate 3™ Left Ventricular Assist System |
Abbott Medical | 11/14/2024 |
|
P180003
S011 |
30-Day Notice | BioMimics 3D® Vascular Stent System | Veryan Medical Ltd. | 11/14/2024 |
|
P190032
S015 |
Normal 180 Day Track | FoundationOne Liquid CDx | Foundation Medicine Inc. | 11/14/2024 |
|
P210032
S018 |
30-Day Notice | GORE® TAG® Thoracic Branch Endoprosthesis |
W. L. Gore & Associates, Inc. |
11/14/2024 |
|
P230040
S006 |
30-Day Notice | Cordella Pulmonary Artery Sensor System (CorPASS) |
Endotronix, Inc. | 11/14/2024 |
|
P890003
S471 |
Real-Time Process | CareLink SmartSync NuPace Application Software |
Medtronic, Inc. | 11/14/2024 |
|
P970003
S245 |
Special (Immediate Track) |
VNS Therapy System | LivaNova USA, Inc. | 11/14/2024 |
|
P980016
S901 |
Real-Time Process | CareLink SmartSync Visia AF App, CareLink SmartSync Evera MRI App, CareLink SmartSync Viva Consulta Syncra Advisa Ensura |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
11/14/2024 |
|
P980035
S790 |
Real-Time Process | CareLink SmartSync Azure Astra App | MEDTRONIC Inc. | 11/14/2024 |
|
P010015
S549 |
30-Day Notice | Attain Bipolar OTW Lead, Attain OTW LV Lead, Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Solara |
MEDTRONIC Inc. | 11/13/2024 |
|
P010031
S871 |
30-Day Notice | Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
11/13/2024 |
|
P010032
S225 |
Real-Time Process | Eterna™ SCS Charging System | Abbott Medical | 11/13/2024 |
|
P020045
S111 |
Normal 180 Day Track No User Fee |
Coaxial Umbilical Cable | Medtronic CryoCath LP | 11/13/2024 |
|
P030036
S150 |
30-Day Notice | Anchoring Sleeve Kit, SelectSecure Lead |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
11/13/2024 |
|
P030050
S053 |
30-Day Notice | SCULPTRA (injectable Poly-l Lactic Acid) |
Q-Med AB | 11/13/2024 |
|
P060039
S117 |
30-Day Notice | Attain StarFix Lead | MEDTRONIC Inc. | 11/13/2024 |
|
P080006
S187 |
30-Day Notice | Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead |
MEDTRONIC Inc. | 11/13/2024 |
|
P090013
S334 |
30-Day Notice | CapSureFix MRI Lead | Medtronic, Inc | 11/13/2024 |
|
P100010
S149 |
Normal 180 Day Track No User Fee |
Manual Retraction Kit | Medtronic CryoCath LP | 11/13/2024 |
|
P120017
S037 |
30-Day Notice | Myocardial Pacing Lead | MEDTRONIC Inc. | 11/13/2024 |
|
P130008
S114 |
30-Day Notice | Model 4063 Inspire Stimulation Lead, Model 4340 Inspire Sensing Lead |
INSPIRE MEDICAL SYSTEMS | 11/13/2024 |
|
P140009
S106 |
Real-Time Process | Liberta RC™ DBS Charging System | Abbott Medical | 11/13/2024 |
|
P150031
S065 |
Normal 180 Day Track | Vercise Genus DBS System, Vercise Gevia DBS System, Vercise PC DBS System |
Boston Scientific Corp. | 11/13/2024 |
|
P150033
S193 |
30-Day Notice | Micra AV TPS, Micra TPS, Micra VR TPS |
MEDTRONIC Inc. | 11/13/2024 |
|
P190030
S003 |
Real-Time Process | ActaStim-S Spine Fusion Stimulator | Theragen, Inc. | 11/13/2024 |
|
P220012
S033 |
30-Day Notice | Aurora EV ICD, Epsila EV Extravascular Lead |
Medtronic, Inc. | 11/13/2024 |
|
P230007
S007 |
Normal 180 Day Track No User Fee |
TriClip G4 System | Abbott Medical | 11/13/2024 |
|
P830055
S330 |
Real-Time Process | ATTUNETM Rotating Platform (RP) Total Knee System, ATTUNETM Cementless Rotating Platform (RP) Knee System, ATTUNETM Revi |
DEPUY, INC. | 11/13/2024 |
|
P830061
S226 |
30-Day Notice | CapSure Sense Lead, CapSure SP Lead, Vitatron Crystalline Lead |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
11/13/2024 |
|
P850089
S170 |
30-Day Notice | CapSure SP Novus Lead, CapSure SP Z Lead, Vitatron Impulse II Lead |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
11/13/2024 |
|
P890003
S473 |
30-Day Notice | CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead |
Medtronic, Inc. | 11/13/2024 |
|
P900061
S174 |
30-Day Notice | End Cap, Epicardial Patch Lead, Sizing Sleeve |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
11/13/2024 |
|
P920015
S294 |
30-Day Notice | DF-1 Connector Port Pin Plug, HV Splitter/Adaptor Kit, IS-1 Connector Port Pin Plug Kit, Lead Adaptor, Sprint Quattro Le |
MEDTRONIC Inc. | 11/13/2024 |
|
P930039
S265 |
30-Day Notice | CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead |
Medtronic, Inc. | 11/13/2024 |
|
P950024
S113 |
30-Day Notice | CapSure Epicardial Pacing Lead | MEDTRONIC Inc. | 11/13/2024 |
|
P970051
S232 |
30-Day Notice | Nucleus CI632 Cochlear Implant, Nucleus CI532 Cochlear Implant |
Cochlear Americas | 11/13/2024 |
|
P980016
S905 |
30-Day Notice | Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
11/13/2024 |
|
P980035
S788 |
Real-Time Process | Azure/Astra Implantable Pulse Generator (IPG) |
MEDTRONIC Inc. | 11/13/2024 |
|
P980035
S797 |
30-Day Notice | Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, |
MEDTRONIC Inc. | 11/13/2024 |
|
P980050
S144 |
30-Day Notice | Transvene CS/SVC Lead | MEDTRONIC Inc. | 11/13/2024 |
|
P130017
S060 |
Real-Time Process | COLOGUARD | Exact Sciences Corporation |
11/12/2024 |
|
P160015
S016 |
Real-Time Process | CPR Uni-padz III | ZOLL MEDICAL CORPORATION | 11/12/2024 |
|
P160022
S038 |
Real-Time Process | CPR-D-padz One-Piece Electrode Pad With Real CPR Help, OneStep CPR Complete Electrode, Pro-padz Biphasic Electrode, Pro- |
ZOLL MEDICAL CORPORATION | 11/12/2024 |
|
P230025
S001 |
Real-Time Process | Xstim Spine Fusion Stimulator | Xstim Inc | 11/12/2024 |
|
P030053
S058 |
Normal 180 Day Track No User Fee |
MemoryGel, MemoryGel Xtra Silicone Gel-Filled Breast Implants |
MENTOR CORP. | 11/08/2024 |
|
P070026
S115 |
30-Day Notice | CERAMAX Ceramic Hip System | DEPUY ORTHOPAEDICS, INC. | 11/08/2024 |
|
P150012
S162 |
Normal 180 Day Track No User Fee |
INGEVITY+ | BOSTONSCIENTIFIC | 11/08/2024 |
|
P240003
S001 |
Normal 180 Day Track No User Fee |
Minima Stent System | Renata Medical, Inc. | 11/08/2024 |
|
P830055
S336 |
30-Day Notice | LCS Total Knee System | DEPUY, INC. | 11/08/2024 |
|
P930038
S103 |
Real-Time Process | Angio-Seal Vascular Closure Device | TERUMO MEDICAL CORPORATION |
11/08/2024 |
|
P010012
S587 |
30-Day Notice | NAV 2 Quadpole LV Straight 86CM 4671, NAV 2 Quadpole LV Straight 95CM 4672, NAV 2 Quadpole LV Short Spiral 86CM 4674, N |
Boston Scientific Corp. | 11/07/2024 |
|
P030004
S036 |
30-Day Notice | Apollo™ Onyx™ Delivery Micro Catheter |
EV3 NEUROVASCULAR | 11/07/2024 |
|
P030017
S378 |
30-Day Notice | Precision Spinal Cord Stimulator (SCS) Systems |
Boston Scientific Corp. | 11/07/2024 |
|
P110042
S200 |
30-Day Notice | EMBLEM S-ICD ELECTRODE 45 CM 3501 | BOSTON SCIENTIFIC CORPORATION |
11/07/2024 |
|
P140004
S034 |
30-Day Notice | Superion Indirect Decompression System (IDS) System |
Boston Scientific Neuromodulation |
11/07/2024 |
|
P140031
S179 |
30-Day Notice | Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra RES |
EDWARDS LIFESCIENCES, LLC. |
11/07/2024 |
|
P150031
S078 |
30-Day Notice | Vercise Deep Brain Stimulation (DBS) Systems |
Boston Scientific Corp. | 11/07/2024 |
|
P150048
S083 |
30-Day Notice | KONECT RESILIA Aortic Valved Conduit (AVC) |
EDWARDS LIFESCIENCES, LLC. |
11/07/2024 |
|
P190002
S033 |
30-Day Notice | Saluda Medical Evoke® SCS System | SALUDA MEDICAL PTY LTD | 11/07/2024 |
|
P190019
S032 |
Normal 180 Day Track | Ranger™ Paclitaxel-Coated PTA Balloon Catheter |
Boston Scientific Corporation |
11/07/2024 |
|
P200015
S059 |
30-Day Notice | Edwards SAPIEN 3 Transcatheter Heart Valve |
Edwards Lifesciences, LLC |
11/07/2024 |
|
P220003
S021 |
Special (Immediate Track) |
PASCAL Precision Transcatheter Valve Repair System |
Edwards LifeSciences LLC | 11/07/2024 |
|
P230011
S001 |
30-Day Notice | TruSight Oncology Comprehensive | Illumina, Inc. | 11/07/2024 |
|
P230032
S002 |
Normal 180 Day Track | AvertD And AvertD Buccal Sample Collection Kit |
AutoGenomics, Inc. | 11/07/2024 |
|
P910073
S180 |
30-Day Notice | LD SEN DF4 IB IR PF DC, LD SEN DF4 IB IR PF SC, LD SEN DF4 IB IR PF SC, LD SEN DF4 IB IR PF DC, LD SEN DF4 IB IR AF SC, |
BOSTON SCIENTIFIC | 11/07/2024 |
|
P000054
S073 |
30-Day Notice | INFUSE™ Bone Graft | Medtronic Sofamor Danek USA, Inc. |
11/06/2024 |
|
P000058
S093 |
30-Day Notice | INFUSE™ Bone Graft/Medtronic Interbody Fusion Device |
Medtronic Sofamor Danek USA, Inc. |
11/06/2024 |
|
P050053
S064 |
30-Day Notice | INFUSE™ Bone Graft | MEDTRONIC Inc. | 11/06/2024 |
|
P170012
S029 |
Normal 180 Day Track | HEMOBLAST™ Bellows | Dilon Technologies, Inc. | 11/06/2024 |
|
P180036
S032 |
Real-Time Process | GUARDIO/VESTA Charger | Impulse Dynamics (USA), Inc. |
11/06/2024 |
| P240006 | Original | VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; Ngen™ Pump) |
Biosense Webster, Inc | 11/06/2024 |
|
P990027
S022 |
Real-Time Process | TECHNOLAS EXCIMER LASER SYSTEM (217A AND 217Z) |
TECHNOLAS PERFECT VISION GMBH |
11/06/2024 |
|
P010015
S550 |
30-Day Notice | Consulta CRT-P, Syncra CRT-P | MEDTRONIC Inc. | 11/05/2024 |
|
P030053
S074 |
Normal 180 Day Track | Mentor MemoryGel® Silicone Gel-Filled Breast Implant PMA |
MENTOR CORP. | 11/05/2024 |
|
P060028
S052 |
Normal 180 Day Track | Mentor MemoryShape® Silicone Gel-Filled Breast Implant PMA |
MENTOR WORLDWIDE LLC | 11/05/2024 |
|
P160037
S020 |
Real-Time Process | BD Onclarity™ HPV Assay | BECTON, DICKINSON AND COMPANY |
11/05/2024 |
|
P170038
S022 |
30-Day Notice | CentriMag Circulatory Support System | Abbott | 11/05/2024 |
|
P180046
S091 |
30-Day Notice | Axonics Sacral Neuromodulation System |
Axonics Modulation Technologies, Inc. |
11/05/2024 |
|
P190006
S091 |
30-Day Notice | Axonics Sacral Neuromodulation System |
Axonics Modulation Technologies, Inc. |
11/05/2024 |
| P240010 | Original | MI Cancer Seek | Caris Life Sciences | 11/05/2024 |
|
P840001
S576 |
30-Day Notice | Master Restore, Itrel®, Synergy®, Intellis™ And Vanta™ Spinal Cord Stimulation Systems And Pisces™, Specify®, Vectris® S |
MEDTRONIC NEUROMODULATION |
11/05/2024 |
|
P960009
S488 |
30-Day Notice | Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ |
MEDTRONIC Inc. | 11/05/2024 |
