| PMA Number | Suppl. Type | Device Name | Applicant | Decision Date |
|---|---|---|---|---|
|
P050048
S010 |
30-Day Notice | MONOLISA ANTI-HBS EIA | BIO-RAD LABORATORIES | 04/18/2025 |
|
P080026
S026 |
30-Day Notice | Abbott RealTime HBV | ABBOTT MOLECULAR, INC. | 04/18/2025 |
|
P100009
S073 |
30-Day Notice | MitraClip Systems | Abbott Medical | 04/18/2025 |
|
P150003
S109 |
30-Day Notice | SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System; SYNERGY XD Everolimus-Eluting Platinum Chromium Coro |
BOSTON SCIENTIFIC CORPORATION |
04/18/2025 |
|
P160017
S118 |
Panel Track | MiniMed 780G System | MEDTRONIC MINIMED, INC. | 04/18/2025 |
|
P200013
S025 |
30-Day Notice | Alinity M HBV | Abbott Molecular, Inc. | 04/18/2025 |
|
P200032
S002 |
30-Day Notice | Occlutech® ASD Occluder And Occlutech® Pistol Pusher |
Occlutech Holding AG | 04/18/2025 |
|
P230003
S007 |
30-Day Notice | Alinity M HR HPV | Abbott Molecular, Inc | 04/18/2025 |
|
P230007
S011 |
30-Day Notice | TriClip Systems | Abbott Medical | 04/18/2025 |
|
P230011
S003 |
30-Day Notice | TruSight Oncology Comprehensive | Illumina, Inc. | 04/18/2025 |
|
P150030
S049 |
30-Day Notice | R3™ Delta Ceramic Acetabular System |
Smith & Nephew, Inc. | 04/17/2025 |
|
P160015
S019 |
30-Day Notice | AED Plus | ZOLL MEDICAL CORPORATION | 04/17/2025 |
|
P160055
S043 |
Real-Time Process | Light Adjustable Lens, Light Delivery Device |
RxSight, Inc. | 04/17/2025 |
|
P200019
S011 |
30-Day Notice | VENTANA MMR RxDx Panel | Ventana Medical Systems | 04/17/2025 |
|
P210001
S014 |
30-Day Notice | VENTANA MMR RxDx Panel | Ventana Medical Systems Inc (Roche Tissue Diagnostics) |
04/17/2025 |
|
P150012
S167 |
30-Day Notice | INGEVITY+ Active Fixation | BOSTONSCIENTIFIC | 04/16/2025 |
|
P150033
S204 |
30-Day Notice | Micra AV TPS MC1AVR1, MC2AVR1; Micra TPS MC1VR01; Micra VR TPS MC2VR01 |
MEDTRONIC Inc. | 04/16/2025 |
|
P190017
S018 |
Normal 180 Day Track | LIAISON® XL Murex HBsAg (REF 318250), LIAISON® Control XL Murex HBsAg (REF 318251) And LIAISON® XL Murex HBsAg Confirmat |
DiaSorin Inc | 04/16/2025 |
|
P200035
S018 |
135 Review Track For 30-Day Notice |
OrganOx Metra System | OrganOx Limited | 04/16/2025 |
|
P230036
S010 |
Normal 180 Day Track No User Fee |
Esprit™ BTK Everolimus Eluting Resorbable Scaffold System |
Abbott Medical | 04/16/2025 |
|
P240006
S006 |
30-Day Notice | VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; Ngen™ Pump) |
Biosense Webster, Inc | 04/16/2025 |
|
P790007
S067 |
30-Day Notice | Hancock Modified Orifice Valved Conduit |
MEDTRONIC HEART VALVES | 04/16/2025 |
|
P970031
S074 |
30-Day Notice | Freestyle Bioprosthesis | Medtronic, Inc. | 04/16/2025 |
|
P980043
S082 |
30-Day Notice | Hancock II Bioprosthesis | Medtronic, Inc. | 04/16/2025 |
|
P990064
S091 |
30-Day Notice | Mosaic Bioprosthesis | Medtronic, Inc. | 04/16/2025 |
|
P000009
S095 |
Normal 180 Day Track | Home Monitoring System Version 3.52.0 |
BIOTRONIK, INC. | 04/15/2025 |
|
P030054
S432 |
30-Day Notice | Avant CDHFA700Q, CDHFA700T; Neutrino NxT CDHFA800Q, CDHFA800T, CDHFA600Q, CDHFA600T; Gallant CDHFA500Q, CDHFA500T; Entra |
Abbott Medical | 04/15/2025 |
|
P050023
S162 |
Normal 180 Day Track | Home Monitoring System Version 3.52.0 |
BIOTRONIK, INC. | 04/15/2025 |
|
P050047
S103 |
30-Day Notice | Ultra, Ultra XC, Ultra Plus XC, Ultra XC |
Allergan | 04/15/2025 |
|
P070008
S131 |
Normal 180 Day Track | Home Monitoring System Version 3.52.0 |
BIOTRONIK, INC. | 04/15/2025 |
|
P110033
S096 |
30-Day Notice | Voluma XC, Vollure XC, Volbella XC, Volux XC, Skinvive |
Allergan | 04/15/2025 |
|
P130010
S003 |
Real-Time Process | Vega Endocardial Pacing Leads | MicroPort CRM USA Inc. | 04/15/2025 |
|
P200035
S023 |
30-Day Notice | OrganOx Metra System | OrganOx Limited | 04/15/2025 |
|
P910023
S476 |
30-Day Notice | Avant CDVRA700Q, CDVRA700T Neutrino NxT CDVRA800Q, CDVRA800T, CDVRA600Q, CDVRA600T, Gallant CDVRA500Q, CDVRA500T Entrant |
Abbott Medical | 04/15/2025 |
|
P950037
S229 |
Normal 180 Day Track | Home Monitoring System Version 3.52.0 |
BIOTRONIK, INC. | 04/15/2025 |
|
P980023
S108 |
Normal 180 Day Track | Home Monitoring System Version 3.52.0 |
BIOTRONIK, INC. | 04/15/2025 |
|
P060040
S117 |
30-Day Notice | HeartMate II Left Ventricular Assist System |
Abbott Medical | 04/14/2025 |
|
P130005
S046 |
30-Day Notice | Diamondback 360™ Coronary Orbital Atherectomy System, Diamondback 360 Precision™ Coronary Orbital Atherectomy System |
CARDIOVASCULAR SYSTEMS, INC. |
04/14/2025 |
|
P140013
S016 |
Normal 180 Day Track No User Fee |
Minerva Endometrial Ablation System | MINERVA SURGICAL | 04/14/2025 |
|
P160054
S103 |
30-Day Notice | HeartMate 3 Left Ventricular Assist System |
Abbott Medical | 04/14/2025 |
|
P200046
S040 |
30-Day Notice | Harmony TPV System | Medtronic, Inc. | 04/14/2025 |
|
N970003
S299 |
30-Day Notice | Essentio SR; Essentio DR; Essentio EL DR; Proponent SR; Proponent DR; Proponent EL DR; Accolade SR; Accolade DR; Accolad |
Boston Scientific Corp. | 04/11/2025 |
|
P010007
S023 |
30-Day Notice | IMMULITE 2000 Alpha-Fetoprotein (AFP) |
SIEMENS HEALTHCARE DIAGNOSTICS INC. |
04/11/2025 |
|
P010012
S589 |
30-Day Notice | Inogen CRT-D; Inogen X4 CRT-D; Dynagen CRT-D; Dynagen X4 CRT-D |
Boston Scientific Corp. | 04/11/2025 |
|
P030005
S245 |
30-Day Notice | Valitude CRT-P; Valitude X4 CRT-P; Visionist CRT-P; Visionisnt X4 CRT-P |
GUIDANT CORP. | 04/11/2025 |
|
P030039
S030 |
30-Day Notice | Coseal Surgical Sealant | BAXTER BIO SCIENCE | 04/11/2025 |
|
P080026
S025 |
30-Day Notice | Abbott RealTime HBV Assay | ABBOTT MOLECULAR, INC. | 04/11/2025 |
|
P100030
S020 |
30-Day Notice | Preveleak Surgical Sealant 4mL; Preveleak Delivery Tips 10 PK |
Baxter Healthcare Corporation |
04/11/2025 |
|
P150012
S166 |
30-Day Notice | Essentio MRI SR; Essentio MRI DR; L131 Essentio MRI EL DR; Proponent; Accolade MRI SR; Accolade MRI DR; Accolade MRI EL |
BOSTONSCIENTIFIC | 04/11/2025 |
|
P170030
S051 |
Special (Immediate Track) |
Orsiro Mission Sirolimus Eluting Coronary Stent System |
Biotronik, Inc | 04/11/2025 |
|
P180046
S098 |
30-Day Notice | Axonics Sacral Neuromodulation System |
Boston Scientific Corporation |
04/11/2025 |
|
P190006
S098 |
30-Day Notice | Axonics Sacral Neuromodulation System |
Boston Scientific Corporation |
04/11/2025 |
|
P200013
S024 |
30-Day Notice | Alinity M HBV Assay | Abbott Molecular, Inc. | 04/11/2025 |
|
P200026
S013 |
30-Day Notice | Abre™ Venous Self-expanding Stent System |
Medtronic Vascular, Inc. | 04/11/2025 |
|
P210032
S015 |
Panel Track | GORE TAG Thoracic Branch Endoprosthesis (TBE Device) |
W. L. Gore & Associates, Inc. |
04/11/2025 |
|
P220013
S018 |
30-Day Notice | TactiFlex Ablation Catheter, Sensor Enabled (TactiFlex SE) |
Abbott Medical | 04/11/2025 |
| P240028 | Original | WiSE® (Wireless Stimulation Of The Endocardium Technology) CRT System |
EBR Systems, Inc. | 04/11/2025 |
|
P840001
S592 |
30-Day Notice | Restore, Itrel®, Synergy®, IntellisTM, VantaTM And InceptivTM Spinal Cord Stimulation Systems And PiscesTM, Specify®, An |
MEDTRONIC NEUROMODULATION |
04/11/2025 |
|
P960009
S504 |
30-Day Notice | Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ |
MEDTRONIC Inc. | 04/11/2025 |
|
P960040
S504 |
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™ MI |
BOSTON SCIENTIFIC | 04/11/2025 |
|
P990065
S017 |
30-Day Notice | SIR-SPHERES | Sirtex Medical Pty Ltd | 04/11/2025 |
|
P040014
S050 |
30-Day Notice | Therapy Ablation Catheter (4mm Tip Thermistor And Bi-Directional); Cables |
IRVINE BIOMEDICAL, INC. | 04/10/2025 |
|
P040042
S057 |
30-Day Notice | Safire TX Ablation Catheter; Safire TX, Catheter Extension Cable; Therapy 8mm Tip Thermistor Ablation Catheter; Therapy |
IRVINE BIOMEDICAL,INC.(IBI) |
04/10/2025 |
|
P110016
S088 |
30-Day Notice | FlexAbility™ Ablation Catheter; FlexAbility™ Ablation Catheter, Sensor Enabled™ |
Abbott Medical | 04/10/2025 |
|
P130026
S093 |
30-Day Notice | TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ |
St. Jude Medical | 04/10/2025 |
|
P220013
S017 |
30-Day Notice | TactiFlex™ Ablation Catheter, Sensor Enabled™ |
Abbott Medical | 04/10/2025 |
|
P220026
S012 |
Normal 180 Day Track No User Fee |
Symplicity G3 Renal Denervation RF Generator; Symplicity Spyral Multi-Electrode Renal Denervation Catheter |
Medtronic Inc. | 04/10/2025 |
|
P830055
S342 |
30-Day Notice | LCS(R) TOTAL KNEE SYSTEM | DEPUY, INC. | 04/10/2025 |
|
P860057
S220 |
Normal 180 Day Track No User Fee |
PERIMOUNT Magna Mitral Ease Pericardial Bioprosthesis |
EDWARDS LIFESCIENCES, LLC. |
04/10/2025 |
|
P960016
S092 |
30-Day Notice | Safire™ Bi-Directional Ablation Catheter; Safire™ Catheter Extension Cable |
St. Jude Medical | 04/10/2025 |
|
P020018
S065 |
30-Day Notice | ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEM |
COOK, INC. | 04/09/2025 |
|
P020036
S054 |
30-Day Notice | S.M.A.R.T. CONTROL Nitinol Stent System; S.M.A.R.T. RADIANZ Vascular Stent System |
Cordis US Corporation | 04/09/2025 |
|
P040027
S098 |
Real-Time Process | GORE® VIATORR® TIPS Endoprosthesis With Controlled Expansion |
W. L. GORE & ASSOCIATES, INC. |
04/09/2025 |
|
P060011
S040 |
30-Day Notice | C-FLEX MODEL 570C INTRAOCULAR LENS (IOL) |
RAYNER INTRAOCULAR LENSES LTD. |
04/09/2025 |
|
P060037
S093 |
30-Day Notice | NexGen© LPSFlex/LPS Mobile Bearing Knee System |
ZIMMER, INC. | 04/09/2025 |
|
P120002
S029 |
30-Day Notice | S.M.A.R.T.; S.M.A.R.T. CONTROL Vascular Stent Systems; S.M.A.R.T. RADIANZ Vascular Stent System |
Cordis US Corporation | 04/09/2025 |
|
P150002
S011 |
30-Day Notice | INCRAFT AAA Stent Graft System | Cordis US Corporation | 04/09/2025 |
|
P150010
S005 |
Panel Track | HYMOVIS ONE | FIDIA FARMACEUTICI | 04/09/2025 |
|
P170030
S053 |
30-Day Notice | ORSIRO Sirolimus Eluting Coronary Stent System |
Biotronik, Inc | 04/09/2025 |
|
P210006
S012 |
30-Day Notice | Thoraflex Hybrid | Vascutek Ltd. | 04/09/2025 |
|
P960058
S168 |
30-Day Notice | HiResolution Bionic Ear System | ADVANCED BIONICS | 04/09/2025 |
|
P130021
S176 |
30-Day Notice | Medtronic Evolut PRO+ Transcatheter Aortic Valve; Medtronic Evolut FX Transcatheter Aortic Valve; Medtronic Evolut FX+ T |
Medtronic, Inc. | 04/08/2025 |
|
P180036
S039 |
Normal 180 Day Track No User Fee |
OPTIMIZER Smart System | Impulse Dynamics (USA), Inc. |
04/08/2025 |
|
P210027
S012 |
Normal 180 Day Track No User Fee |
QDOT MICRO™ System | Biosense Webster, Inc. | 04/08/2025 |
|
P960022
S013 |
Real-Time Process | SofLens® Toric (alphafilcon A) Visibility Tinted Contact Lenses |
Bausch & Lomb, Inc. | 04/08/2025 |
|
P100021
S128 |
30-Day Notice | Endurant Stent Graft System; Endurant II Stent Graft System; Endurant II Stent AUI Graft System; Endurant IIs Stent Graf |
Medtronic Vascular | 04/07/2025 |
|
P100040
S071 |
30-Day Notice | Valiant Thoracic Stent Graft With The Captivia Delivery System |
Medtronic Vascular | 04/07/2025 |
|
P130021
S175 |
30-Day Notice | CoreValve EnVeo Pro Delivery Catheter System; CoreValve EnVeo Pro Loading System; Evolut PRO+ Delivery Catheter System; |
Medtronic, Inc. | 04/07/2025 |
|
P160043
S087 |
30-Day Notice | Resolute Onyx Zotarolimus Eluting Coronary Stent System RX And OTW; Onyx Frontier Zotarolimus Eluting Coronary Stent Sys |
MEDTRONIC VASCULAR | 04/07/2025 |
|
P160054
S102 |
30-Day Notice | HeartMate 3™ Left Ventricular Assist System |
Abbott Medical | 04/07/2025 |
|
P200046
S038 |
30-Day Notice | Harmony™ Delivery Catheter System | Medtronic, Inc. | 04/07/2025 |
|
P200046
S039 |
30-Day Notice | Harmony Transcatheter Pulmonic Valve (TPV) System |
Medtronic, Inc. | 04/07/2025 |
|
P220026
S011 |
30-Day Notice | Symplicity Spyral Renal Denervation Catheter |
Medtronic Inc. | 04/07/2025 |
|
P030047
S049 |
Panel Track | PRECISE PRO RX Transcarotid Stent System |
Cordis US Corporation | 04/04/2025 |
|
P050018
S035 |
135 Review Track For 30-Day Notice |
AngioSculpt Evo RX PTCA Scoring Balloon Catheter With Hydrophilic Coating |
SPECTRANETICS CORP. | 04/04/2025 |
|
P070026
S119 |
30-Day Notice | CERAMAX CERAMIC HIP SYSTEM | DEPUY ORTHOPAEDICS, INC. | 04/04/2025 |
|
P150038
S038 |
30-Day Notice | Exablate Model 4000 System | InSightec | 04/04/2025 |
|
P150038
S040 |
30-Day Notice | Exablate 4000; Exablate Transcarnial MRgFUS; Exablate Neuro; Exablate Prime; ExAblate Neuravive |
InSightec | 04/04/2025 |
|
P200044
S008 |
Real-Time Process | LungFit PH | Beyond Air, Inc. | 04/04/2025 |
|
P000009
S118 |
Real-Time Process | Renamic Neo | BIOTRONIK, INC. | 04/03/2025 |
|
P010015
S560 |
30-Day Notice | Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Solara Bipolar CRT-P |
MEDTRONIC Inc. | 04/03/2025 |
|
P010031
S887 |
30-Day Notice | Amplia MRI CRT-D; Amplia MRI Quad CRT-D; Brava CRT-D; Brava CRT-D; Brava Quad CRT-D; Brava Quad CRT-D; Claria MRI CRT-D; |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
04/03/2025 |
|
P050023
S192 |
Real-Time Process | Renamic Neo | BIOTRONIK, INC. | 04/03/2025 |
|
P050051
S061 |
30-Day Notice | ARCHITECT AUSAB; Alinity I Anti-HBs | ABBOTT LABORATORIES INC | 04/03/2025 |
|
P060035
S043 |
30-Day Notice | ARCHITECT CORE-M / Alinity I Anti-HBc IgM |
Abbott Laboratories | 04/03/2025 |
|
P070008
S164 |
Real-Time Process | Renamic Neo | BIOTRONIK, INC. | 04/03/2025 |
|
P080023
S046 |
30-Day Notice | ARCHITECT CORE / Alinity I Anti-HBc | Abbott Laboratories | 04/03/2025 |
|
P110029
S052 |
30-Day Notice | ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity I HBsAg Qualitative II/Qualitative II Confirmatory |
Abbott Laboratories | 04/03/2025 |
|
P120008
S030 |
30-Day Notice | ARCHITECT AFP / Alinity I AFP | Abbott Laboratories | 04/03/2025 |
|
P150003
S108 |
30-Day Notice | SYNERGY™ XD And SYNERGY™ MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System |
BOSTON SCIENTIFIC CORPORATION |
04/03/2025 |
|
P150035
S022 |
30-Day Notice | Aveir VR Leadless System | Abbott Medical | 04/03/2025 |
|
P160026
S057 |
30-Day Notice | LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15 MONITOR/DE |
Physio-Control. Inc. | 04/03/2025 |
|
P210003
S013 |
30-Day Notice | ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity I HBsAg Next Qualitative/Alinity I HBsAg N |
Abbott Laboratories | 04/03/2025 |
|
P220012
S047 |
30-Day Notice | Aurora EV-ICD | Medtronic, Inc. | 04/03/2025 |
|
P230030
S011 |
30-Day Notice | FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARASTAR™ Catheter Connection Cable, |
FARAPULSE, Inc. | 04/03/2025 |
|
P910007
S066 |
30-Day Notice | ARCHITECT Total PSA / Alinity I Total PSA |
Abbott Laboratories | 04/03/2025 |
|
P950037
S269 |
Real-Time Process | Renamic Neo | BIOTRONIK, INC. | 04/03/2025 |
|
P980007
S055 |
30-Day Notice | ARCHITECT Free PSA / Alinity I Free PSA |
Abbott Laboratories | 04/03/2025 |
|
P980016
S921 |
30-Day Notice | Evera MRI DF-1 ICD; Evera MRI DF-1 ICD; Evera MRI ICD; Evera MRI ICD; Evera S DR ICD; Evera S VR ICD; Evera XT VR ICD; M |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
04/03/2025 |
|
P980035
S809 |
30-Day Notice | Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT DR MRI IPG; Astra XT SR MRI IPG; Azure S DR MRI IPG; Azure S SR MRI IPG |
MEDTRONIC Inc. | 04/03/2025 |
|
P010031
S886 |
30-Day Notice | Amplia MRI CRT-D DTMB1D1, DTMB1D4 Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ Brava CRT-D DTBC1D1 Brava CRT-D DTBC1D4 Brava Q |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
04/02/2025 |
|
P060022
S034 |
30-Day Notice | AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS,MODEL ADAPT |
Bausch & Lomb, Inc. | 04/02/2025 |
|
P100047
S224 |
30-Day Notice | HeartWare HVAD System | Medtronic | 04/02/2025 |
|
P180046
S089 |
135 Review Track For 30-Day Notice |
Axonics Sacral Neuromodulation System |
Boston Scientific Corporation |
04/02/2025 |
|
P190006
S089 |
135 Review Track For 30-Day Notice |
Axonics Sacral Neuromodulation System |
Boston Scientific Corporation |
04/02/2025 |
|
P220012
S046 |
30-Day Notice | Aurora EV ICD DVEA3E4 | Medtronic, Inc. | 04/02/2025 |
|
P980016
S920 |
30-Day Notice | Cobalt MRI ICD DVPB3D4 Cobalt MRI ICD DDPB3D1, DDPB3D4, DVPB3D1 Cobalt XT MRI ICD DDPA2D1, DVPA2D1, DVPA2D4 Cobalt XT MR |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
04/02/2025 |
|
P030035
S198 |
Normal 180 Day Track | Anthem, Allure/RF, Allure Quadra/RF Family Of CRT-Ps |
Abbott Medical | 04/01/2025 |
|
P030036
S152 |
30-Day Notice | SelectSecure Lead | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
04/01/2025 |
|
P030054
S416 |
Normal 180 Day Track | Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ |
Abbott Medical | 04/01/2025 |
|
P040047
S076 |
30-Day Notice | Coaptite | MERZ NORTH AMERICA, INC | 04/01/2025 |
|
P050037
S143 |
30-Day Notice | RADIESSE Injectable Implant | MERZ NORTH AMERICA, INC | 04/01/2025 |
|
P050047
S102 |
30-Day Notice | JUVEDERM 24HV, JUVEDERM 30 AND JUVEDERM 30HV GEL IMPLANTS |
Allergan | 04/01/2025 |
|
P050052
S167 |
30-Day Notice | RADIESSE Injectable Implant; RADIESSE Hands; RADIESSE (+) Lidocaine |
MERZ NORTH AMERICA, INC | 04/01/2025 |
|
P060037
S094 |
30-Day Notice | NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM |
ZIMMER, INC. | 04/01/2025 |
|
P110033
S095 |
30-Day Notice | JUVEDERM VOLUMA XC | Allergan | 04/01/2025 |
|
P140033
S084 |
Normal 180 Day Track | Assurity MRI, Endurity MRI Family Of Pacemakers |
Abbott Medical | 04/01/2025 |
|
P150011
S032 |
30-Day Notice | PERCEVAL SUTURELESS HEART VALVE | Corcym S.r.l. | 04/01/2025 |
|
P880086
S333 |
Normal 180 Day Track | Assurity, Assurity+, Endurity, Accent Family Of Pacemakers |
Abbott Medical | 04/01/2025 |
|
P910023
S461 |
Normal 180 Day Track | Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II+/Avant/Neutrino NxT/Gallant/Ent |
Abbott Medical | 04/01/2025 |
|
P920015
S298 |
30-Day Notice | Sprint Quattro Lead | MEDTRONIC Inc. | 04/01/2025 |
|
P970013
S094 |
Normal 180 Day Track | Microny Family Of Pacemakers | Abbott Medical | 04/01/2025 |
|
P020025
S145 |
30-Day Notice | RHYTHMIA HDx™ Ablation Connection Box (for INTELLAGEN™); Rhythmia HDx™ Ablation Connection Box (Maestro™) |
BOSTON SCIENTIFIC | 03/31/2025 |
|
P070006
S024 |
Normal 180 Day Track | T-SPOT TB | OXFORD IMMUNOTEC,LTD. | 03/31/2025 |
|
P150005
S087 |
30-Day Notice | RHYTHMIA HDx™ Ablation Connection Box (for INTELLAGEN™); Rhythmia HDx™ Ablation Connection Box (Maestro™);RHYTHMIA HDx™ |
Boston Scientific Corp. | 03/31/2025 |
|
P170012
S030 |
30-Day Notice | HEMOBLAST™ Bellows | Dilon Technologies, Inc. | 03/31/2025 |
|
P920047
S136 |
30-Day Notice | RHYTHMIA HDx™ Ablation Connection Box (for INTELLAGEN™) |
Boston Scientific Corp. | 03/31/2025 |
|
P040037
S168 |
30-Day Notice | GORE VIABAHN Endoprosthesis, GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface |
W.L. GORE & ASSOCIATES,INC |
03/28/2025 |
|
P130006
S107 |
30-Day Notice | GORE VIABAHN Endoprosthesis, GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface |
W.L. GORE & ASSOCIATES,INC |
03/28/2025 |
|
P130022
S068 |
30-Day Notice | Senza HFX Iq System | Nevro Corporation | 03/28/2025 |
|
P210006
S010 |
Normal 180 Day Track | Thoraflex™ Hybrid | Vascutek Ltd. | 03/28/2025 |
|
P990071
S066 |
30-Day Notice | STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR |
BIOSENSE WEBSTER, INC. | 03/28/2025 |
|
P000039
S082 |
30-Day Notice | Amplatzer™ Septal Occluder; Amplatzer™ Amulet™ Left Atrial Appendage Occluder |
Abbott Medical | 03/27/2025 |
|
P020045
S112 |
30-Day Notice | 7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM |
Medtronic CryoCath LP | 03/27/2025 |
|
P100010
S150 |
30-Day Notice | ARCTIC FRONT CRYOCATHETER SYSTEM | Medtronic CryoCath LP | 03/27/2025 |
|
P100018
S050 |
30-Day Notice | Pipeline Flex Embolization Device; Pipeline Flex Embolization Device With Shield Technology (Pipeline™ Shield) |
Micro Therapeutics, Inc. d/b/a ev3 NEUROVASCULAR |
03/27/2025 |
|
P100020
S062 |
Normal 180 Day Track No User Fee |
Cobas HPV TEST | Roche Molecular Systems, Inc. |
03/27/2025 |
|
P140017
S030 |
30-Day Notice | MELODY TRANSCATHETER PULMONARY VALVE (TPV), ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM (DS) |
MEDTRONIC Inc. | 03/27/2025 |
|
P150033
S203 |
30-Day Notice | MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM |
MEDTRONIC Inc. | 03/27/2025 |
|
P160048
S029 |
Normal 180 Day Track No User Fee |
EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM |
Senseonics, Incorporated | 03/27/2025 |
|
P170002
S040 |
135 Review Track For 30-Day Notice |
RHA® Redensity , RHA®2, RHA®3, RHA®4, RHA® Redensity Mepi, RHA® 2 Mepi, RHA® 3 Mepi, RHA® 4 Mepi |
TEOXANE S.A. | 03/27/2025 |
|
P180036
S033 |
135 Review Track For 30-Day Notice |
OPTIMIZER Smart, OPTIMIZER Smart Mini, OPTIMIZER Lite |
Impulse Dynamics (USA), Inc. |
03/27/2025 |
|
P190028
S019 |
Normal 180 Day Track No User Fee |
Cobas HPV For Use On The Cobas 6800/8800 Systems |
Roche Molecular Systems, Inc. |
03/27/2025 |
|
P200049
S011 |
30-Day Notice | Amplatzer™ Amulet™ Left Atrial Appendage Occluder |
Abbott Medical | 03/27/2025 |
|
P970003
S246 |
Real-Time Process | VNS Therapy® SenTiva® Model 1000 Generator, VNS Therapy® AspireSR Model 106 Generator, VNS Therapy® Demipulse Model 103 |
LivaNova USA, Inc. | 03/27/2025 |
|
P140010
S087 |
135 Review Track For 30-Day Notice |
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter, IN.PACT 018 Paclitaxel-Coated |
MEDTRONIC Inc. | 03/26/2025 |
|
P190008
S036 |
135 Review Track For 30-Day Notice |
IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter |
Medtronic Vascular Inc. | 03/26/2025 |
|
P240006
S004 |
Special (Immediate Track) |
VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; Ngen™ Pump) |
Biosense Webster, Inc | 03/26/2025 |
|
P080011
S185 |
30-Day Notice | Biofinity Sphere (comfilcon A) Soft (Hydrophilic) Contact Lenses For Extended Wear |
CooperVision, Inc. | 03/25/2025 |
|
P100034
S039 |
30-Day Notice | Optune® | Novocure GmbH | 03/25/2025 |
|
P140031
S185 |
30-Day Notice | Crimper | EDWARDS LIFESCIENCES, LLC. |
03/25/2025 |
|
P150038
S026 |
Normal 180 Day Track No User Fee |
Exablate Model 4000 Type 1.0 And 1.1 Systems (“Exablate Neuro”) |
InSightec | 03/25/2025 |
|
P200015
S062 |
30-Day Notice | Crimper | Edwards Lifesciences, LLC |
03/25/2025 |
|
P220002
S006 |
Normal 180 Day Track | TOPS™ System | Premia Spine Ltd. | 03/25/2025 |
|
P220023
S008 |
30-Day Notice | Paradise Ultrasound Renal Denervation System; Paradise Catheter |
ReCor Medical, Inc. | 03/25/2025 |
|
P210037
S006 |
Normal 180 Day Track | Prospera SCS System, Resilience Surgical Lead, Embrace One |
Biotronik NRO, Inc. | 03/24/2025 |
|
P220030
S005 |
30-Day Notice | UNIPURE C3F8 Ophthalmic Gas In The UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas In The UNIPEXY Gas Delivery |
Alcon Research, LLC | 03/24/2025 |
|
P230012
S005 |
30-Day Notice | UNIPURE SF6 Ophthalmic Gas In The UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas In The UNIPEXY Gas Delivery Sy |
Alcon Research, LLC. | 03/24/2025 |
|
N12159
S102 |
135 Review Track For 30-Day Notice |
SURGICEL® Absorbable Hemostats And SURGICEL® POWDER Absorbable Hemostatic Powder |
ETHICON, INC. | 03/21/2025 |
|
P210035
S003 |
Normal 180 Day Track | AccelStim | Orthofix US LLC | 03/21/2025 |
|
P220002
S007 |
30-Day Notice | TOPS™ System | Premia Spine Ltd. | 03/21/2025 |
|
P220026
S013 |
30-Day Notice | Symplicity Spyral Multi-Electrode Renal Denervation Catheter |
Medtronic Inc. | 03/21/2025 |
|
P220032
S010 |
Special (Immediate Track) |
Boston Scientific Cardiac Cryoablation System |
Boston Scientific Corporation |
03/21/2025 |
|
P930014
S154 |
Normal 180 Day Track No User Fee |
AcrySof Posterior Chamber Intraocular Lenses |
ALCON LABORATORIES, INC. | 03/21/2025 |
|
BP170154
S023 |
30-Day Notice | ID CORE XT | Progenika Biopharma, S.A. |
03/21/2025 |
|
P200017
S003 |
Normal 180 Day Track | Atellica IM Anti-HBe2 (aHBe2) | Siemens Healthcare Diagnostics, Inc. |
03/20/2025 |
|
P010015
S558 |
135 Review Track For 30-Day Notice |
Medtronic Insync Biventrical Pacing System |
MEDTRONIC Inc. | 03/20/2025 |
|
P010031
S884 |
135 Review Track For 30-Day Notice |
Concerto/Insync Sentry/Insync Maximo Implantable Cardiovascular Defibrillators With Cardiac Resynchicnization |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
03/20/2025 |
|
P020025
S144 |
30-Day Notice | IntellaNav MiFi XP Ablation Catheter | BOSTON SCIENTIFIC | 03/20/2025 |
|
P030036
S151 |
135 Review Track For 30-Day Notice |
Medtronic Selectsecure Lead Model 3830 |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
03/20/2025 |
|
P050037
S142 |
30-Day Notice | RADIESSE Injectable Implant | MERZ NORTH AMERICA, INC | 03/20/2025 |
|
P050052
S166 |
30-Day Notice | RADIESSE Injectable Implant; RADIESSE Hands; RADIESSE (+) Lidocaine Dermal Filler; RADIESSE (+) Jawline |
MERZ NORTH AMERICA, INC | 03/20/2025 |
|
P060039
S118 |
135 Review Track For 30-Day Notice |
Attain Starfix Model 4195 Lead | MEDTRONIC Inc. | 03/20/2025 |
|
P080006
S190 |
135 Review Track For 30-Day Notice |
Medtronic Attain Ability Model 4196 Lead |
MEDTRONIC Inc. | 03/20/2025 |
|
P090013
S336 |
135 Review Track For 30-Day Notice |
Revo MRI Surescan IPG And Pacing System |
Medtronic, Inc | 03/20/2025 |
|
P120017
S038 |
135 Review Track For 30-Day Notice |
Model 5071 Lead | MEDTRONIC Inc. | 03/20/2025 |
|
P130017
S061 |
Real-Time Process | Cologuard® | Exact Sciences Corporation |
03/20/2025 |
|
P150033
S201 |
135 Review Track For 30-Day Notice |
Medtronic Micra Transcatheter Pacemaker System |
MEDTRONIC Inc. | 03/20/2025 |
|
P220012
S043 |
135 Review Track For 30-Day Notice |
Aurora EV-ICD System | Medtronic, Inc. | 03/20/2025 |
|
P220020
S004 |
30-Day Notice | Lava Liquid Embolic System (Lava LES) And Lava Mixing Kit |
BlackSwan Vascular, Inc. | 03/20/2025 |
