| PMA Number | Suppl. Type | Device Name | Applicant | Decision Date |
|---|---|---|---|---|
|
P190002
S045 |
Real-Time Process | Saluda Medical Evoke® SCS System | SALUDA MEDICAL PTY LTD | 11/08/2025 |
|
P010032
S243 |
Normal 180 Day Track | Spinal Cord Stimulation (SCS) Neurostimulation System |
Abbott Medical | 11/07/2025 |
|
P060001
S052 |
Real-Time Process | Protégé GPS Self-expanding Peripheral Stent System |
MEDTRONIC VASCULAR INC | 11/07/2025 |
|
P100044
S058 |
Real-Time Process | Propel Contour Sinus Implant | INTERSECT ENT | 11/07/2025 |
|
P110023
S061 |
Real-Time Process | EverFlex Self-expanding Peripheral Stent System (EverFlex) |
MEDTRONIC VASCULAR INC | 11/07/2025 |
|
P140009
S124 |
Normal 180 Day Track | Deep Brain Stimulation (DBS) Neurostimulation System |
Abbott Medical | 11/07/2025 |
|
P150004
S090 |
Normal 180 Day Track | Dorsal Root Ganglion (DRG) Neurostimulation System |
Abbott Medical | 11/07/2025 |
|
P240027
S004 |
Real-Time Process | SpineSeal™ Spine Sealant | Pramand, LLC | 11/07/2025 |
|
P130013
S081 |
Special (Immediate Track) |
WATCHMAN FLX Pro Left Atrial Appendage Closure Device With Delivery System; WATCHMAN FLX Left Atrial Appendage Closure D |
Boston Scientific Corp. | 11/06/2025 |
|
P130014
S021 |
135 Review Track For 30-Day Notice |
Adherus AutoSpray Dural Sealant | Stryker Leibinger, GmbH & Co KG |
11/06/2025 |
|
P170018
S023 |
Real-Time Process | LIFEPAK® CR2 Automated External Defibrillator |
Physio-Control, Inc | 11/06/2025 |
|
P240024
S002 |
Normal 180 Day Track No User Fee |
Genio® System 2.1 | Nyxoah S.A. | 11/06/2025 |
| P240026 | Original | OncoMate® MSI Dx Analysis System | Promega Corporation | 11/05/2025 |
|
N12159
S122 |
Real-Time Process | SURGICEL® Absorbable Hemostats | ETHICON, INC. | 11/04/2025 |
|
P040024
S142 |
Panel Track | Restylane® Lyft With Lidocaine | Q-Med AB | 11/04/2025 |
|
P160054
S112 |
Real-Time Process | HeartMate 3™ Left Ventricular Assist System (LVAS) |
Abbott Medical | 11/04/2025 |
|
P840001
S596 |
Real-Time Process | Master Restore™, Itrel™, Synergy Intellis™, Vanta™ And Inceptiv™ Spinal Cord Stimulation Systems And Pisces™, Specify™, |
MEDTRONIC NEUROMODULATION |
11/04/2025 |
|
P980041
S051 |
Normal 180 Day Track | Access AFP (on DxI 9000 Analyzer) | BECKMAN COULTER, INC. | 11/03/2025 |
|
P180027
S013 |
Normal 180 Day Track No User Fee |
Flow Re-Direction Endoluminal Device (FRED®) System |
MicroVention, Inc. | 11/02/2025 |
|
P230013
S013 |
Normal 180 Day Track | Edwards EVOQUE Tricuspid Valve Replacement System |
Edwards Lifesciences LLC | 10/31/2025 |
|
P010007
S024 |
30-Day Notice | IMMULITE 2000 AFP | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
10/30/2025 |
|
P040021
S060 |
30-Day Notice | Epic™, Epic™ Supra, Epic™ Plus, Epic™ Plus Supra And Epic™ Max Stented Tissue Valve |
Abbott Medical | 10/30/2025 |
|
P060005
S023 |
30-Day Notice | IMMULITE 2000 Free PSA | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED |
10/30/2025 |
|
P170006
S041 |
30-Day Notice | Avalus Bioprosthesis | Medtronic Inc. | 10/30/2025 |
|
P220013
S023 |
30-Day Notice | TactiFlex™ Ablation Catheter, Sensor Enabled ™ (TactiFlex SE) |
Abbott Medical | 10/30/2025 |
|
P230009
S009 |
30-Day Notice | Shield | Guardant Health, Inc. | 10/30/2025 |
|
P240036
S003 |
30-Day Notice | OmniaSecure™ MRI SureScan™ Lead Model 3930M |
Medtronic, Inc. | 10/30/2025 |
|
P890003
S481 |
Normal 180 Day Track No User Fee |
SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071 |
Medtronic, Inc. | 10/30/2025 |
|
P930027
S037 |
30-Day Notice | IMMULITE 2000 PSA | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
10/30/2025 |
|
P110002
S037 |
Normal 180 Day Track No User Fee |
LDR Spine Mobi-C® Cervical Disc Prosthesis |
Zimmer Biomet Spine, Inc. |
10/29/2025 |
|
P110009
S037 |
Normal 180 Day Track No User Fee |
LDR Spine Mobi-C® Cervical Disc Prosthesis |
Zimmer Biomet Spine, Inc. |
10/29/2025 |
|
P150003
S110 |
30-Day Notice | SYNERGYTM Everolimus-Eluting Platinum Chromium Coronary Stent System |
BOSTON SCIENTIFIC CORPORATION |
10/29/2025 |
|
P170027
S020 |
30-Day Notice | TherOx Downstream System | ZOLL Circulation, Inc. | 10/29/2025 |
|
P200041
S009 |
30-Day Notice | Scoreflex NC Scoring PTCA Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. |
10/29/2025 |
|
P210006
S015 |
30-Day Notice | Thoraflex™ Hybrid | Vascutek Ltd. | 10/29/2025 |
|
P220002
S010 |
30-Day Notice | TOPS™ System | Premia Spine Ltd. | 10/29/2025 |
|
P240036
S002 |
30-Day Notice | OmniaSecure™ MRI SureScan™ Lead Model 3930M |
Medtronic, Inc. | 10/29/2025 |
|
P980023
S141 |
30-Day Notice | Pamira S 60 428768 Pamira S 65 428769 Pamira S 75 428770 Pamira SD 60/16 428771 Pamira SD 65/16 428772 Pamira SD 65/18 4 |
BIOTRONIK, INC. | 10/29/2025 |
|
P010031
S906 |
30-Day Notice | Amplia MRI CRT-D (DTMB1D1, DTMB1D4); Amplia MRI Quad CRT-D (DTMB1Q1, DTMB1QQ); Brava CRT-D (DTBC1D1, DTBC1D4); Brava Qua |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
10/28/2025 |
|
P150011
S033 |
30-Day Notice | PERCEVAL SUTURELESS HEART VALVE | Corcym S.r.l. | 10/28/2025 |
|
P150011
S034 |
30-Day Notice | Perceval Sutureless Heart Valve | Corcym S.r.l. | 10/28/2025 |
|
P150035
S033 |
30-Day Notice | Aveir VR Leadless Pacemaker; Aveir Leadless Pacemaker (Right Atrium); Aveir Leadless Pacemaker (Right Ventricle) |
Abbott Medical | 10/28/2025 |
|
P180035
S031 |
Normal 180 Day Track No User Fee |
MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses For Daily Wear |
CooperVision, Inc. | 10/28/2025 |
|
P190013
S001 |
Normal 180 Day Track | DBP-1400-ABE And DBP-2003- ABE | AED Battery Exchange, LLC |
10/28/2025 |
|
P220012
S059 |
30-Day Notice | Aurora EV ICD (DVEA3E4) | Medtronic, Inc. | 10/28/2025 |
|
P810031
S080 |
30-Day Notice | Healon EndoCoat ™ PRO Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD), Healon Duet ™ PRO II Dual Pack Sodium Hya |
Johnson & Johnson Surgical Vision, Inc. |
10/28/2025 |
|
P980016
S939 |
30-Day Notice | Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
10/28/2025 |
|
P150048
S092 |
Panel Track | TRIFORMIS RESILIA Tricuspid Valve | EDWARDS LIFESCIENCES, LLC. |
10/27/2025 |
|
P040027
S099 |
Normal 180 Day Track | GORE® VIATORR® TIPS Endoprosthesis With Controlled Expansion |
W. L. GORE & ASSOCIATES, INC. |
10/27/2025 |
|
P900056
S222 |
30-Day Notice | ROTAPRO™ Rotational Atherectomy System |
Boston Scientific Corp. | 10/27/2025 |
|
N16895
S107 |
30-Day Notice | Bausch & Lomb SofLens® (polymacon) Contact Lenses |
Bausch & Lomb, Inc. | 10/24/2025 |
|
P010012
S593 |
Real-Time Process | ACUITY X4 Leads | Boston Scientific Corp. | 10/24/2025 |
|
P090016
S068 |
30-Day Notice | Belotero Balance (+) Lidocaine Dermal Filler |
MERZ NORTH AMERICA, INC | 10/24/2025 |
|
P140028
S084 |
30-Day Notice | Innova™ Vascular Self-Expanding Stent System |
BOSTON SCIENTIFIC CORPORATION |
10/24/2025 |
|
P180011
S067 |
30-Day Notice | Eluvia™ Drug-Eluting Vascular Stent System |
Boston Scientific Corp. | 10/24/2025 |
|
P190016
S010 |
30-Day Notice | Tula® System | Tusker Medical, Inc. | 10/24/2025 |
|
P190019
S039 |
30-Day Notice | Ranger™ Paclitaxel-Coated PTA Balloon Catheter |
Boston Scientific Corporation |
10/24/2025 |
|
P230001
S011 |
30-Day Notice | ColoSense® | Geneoscopy, Inc. | 10/24/2025 |
|
P230035
S007 |
30-Day Notice | AGENT™ Paclitaxel-Coated Balloon Catheter |
Boston Scientific Corporation |
10/24/2025 |
|
P910073
S182 |
Real-Time Process | ENDOTAK RELIANCE Leads | BOSTON SCIENTIFIC | 10/24/2025 |
|
P960004
S109 |
Real-Time Process | FINELINE II Leads | BOSTON SCIENTIFIC | 10/24/2025 |
|
P980040
S178 |
30-Day Notice | TECNIS Symfony Toric II OptiBlue Extended Range Of Vision IOL With TECNIS Simplicity Delivery System, Models DXW150-375; |
Johnson & Johnson Surgical Vision, Inc. |
10/24/2025 |
|
BP140143
1098 |
30-Day Notice | INTERCEPT(R) Blood Systerm For Platelets |
Cerus Corporation | 10/23/2025 |
|
P000039
S083 |
30-Day Notice | Amplatzer™ Septal Occluder; Amplatzer™ Multi-Fenestrated Septal Occluder - Cribriform |
Abbott Medical | 10/23/2025 |
|
P020024
S071 |
30-Day Notice | Amplatzer™ Duct Occluder; Amplatzer™ Duct Occluder II; Amplatzer Piccolo™ Occluder |
Abbott Medical | 10/23/2025 |
|
P040040
S050 |
30-Day Notice | Amplatzer™ Muscular VSD Occluder | Abbott Medical | 10/23/2025 |
|
P100021
S131 |
30-Day Notice | Endurant II/IIs Stent Graft System | Medtronic Vascular | 10/23/2025 |
|
P100034
S041 |
Normal 180 Day Track | Optune Gio™ - Maxpoint Version 2.0 | Novocure GmbH | 10/23/2025 |
|
P120021
S027 |
30-Day Notice | Amplatzer™ PFO Occluder; Amplatzer™ Talisman™ PFO Occluder |
Abbott Medical | 10/23/2025 |
|
P140017
S032 |
30-Day Notice | Melody™ Transcatheter Pulmonary Valve |
MEDTRONIC Inc. | 10/23/2025 |
|
P140026
S032 |
30-Day Notice | ENROUTE® Transcarotid Stent System | Boston Scientific Corporation |
10/23/2025 |
|
P170006
S039 |
30-Day Notice | Avalus Bioprosthesis, Model 400 | Medtronic Inc. | 10/23/2025 |
|
P200046
S044 |
30-Day Notice | Harmony™ Transcatheter Pulmonary Valve |
Medtronic, Inc. | 10/23/2025 |
|
P200049
S013 |
30-Day Notice | Amplatzer™ Amulet™ Left Atrial Appendage Occluder |
Abbott Medical | 10/23/2025 |
|
P210037
S013 |
30-Day Notice | Prospera SCS System; Resilience Percutaneous Lead; Embrace One; TrueLock |
Biotronik NRO, Inc. | 10/23/2025 |
|
P840001
S612 |
30-Day Notice | Master Restore™, Itrel™, Synergy™, Intellis™, Vanta™ And Inceptiv™ Spinal Cord Stimulation Systems And Pisces-Quad™, Spe |
MEDTRONIC NEUROMODULATION |
10/23/2025 |
|
P960009
S523 |
30-Day Notice | Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ |
MEDTRONIC Inc. | 10/23/2025 |
|
P970031
S077 |
30-Day Notice | Freestyle Bioprosthesis, Models 995, 995CS, 995MS |
Medtronic, Inc. | 10/23/2025 |
|
P980043
S085 |
30-Day Notice | Hancock II Bioprosthesis, Models T505, T510 |
Medtronic, Inc. | 10/23/2025 |
|
P990064
S095 |
30-Day Notice | Mosaic Bioprosthesis, Models 305, 310 |
Medtronic, Inc. | 10/23/2025 |
|
N970003
S303 |
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. | 10/22/2025 |
|
P000037
S063 |
30-Day Notice | On-X Heart Valve; On-X Ascending Aortic Prosthesis |
On-X Life Technologies, Inc. |
10/22/2025 |
|
P000037
S064 |
30-Day Notice | On-X Prosthetic Heart Valves; On-X Ascending Aortic Prothesis |
On-X Life Technologies, Inc. |
10/22/2025 |
|
P000037
S065 |
30-Day Notice | On-X Prosthetic Heart Valves And Ascending Aortic Prothesis |
On-X Life Technologies, Inc. |
10/22/2025 |
|
P000037
S066 |
30-Day Notice | On-X Prosthetic Heart Valves And Ascending Aortic Prothesis (AAP) |
On-X Life Technologies, Inc. |
10/22/2025 |
|
P010012
S598 |
30-Day Notice | G124 MOMENTUM™ CRT-D, G125 MOMENTUM™ CRT-D, G126 MOMENTUM™ CRT-D, G128 MOMENTUM, G138 MOMENTUM™ X4 CRT-D, G140 INOGEN™ C |
Boston Scientific Corp. | 10/22/2025 |
|
P010012
S599 |
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. | 10/22/2025 |
|
P030005
S249 |
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. | 10/22/2025 |
|
P040012
S066 |
30-Day Notice | RX Acculink | ABBOTT VASCULAR | 10/22/2025 |
|
P050017
S025 |
Special (Immediate Track) |
Zilver Flex® 35 Vascular Stent | Cook Ireland, Ltd. | 10/22/2025 |
|
P110001
S022 |
30-Day Notice | RX Herculink Elite | ABBOTT VASCULAR | 10/22/2025 |
|
P110019
S137 |
30-Day Notice | XIENCE Alpine™ Everolimus Eluting Coronary Stent System (XIENCE Alpine OTW) |
ABBOTT VASCULAR | 10/22/2025 |
|
P110028
S025 |
30-Day Notice | Absolute Pro Vascular | ABBOTT VASCULAR INC. | 10/22/2025 |
|
P110042
S206 |
30-Day Notice | A209 SICD Gen 2,A219 SICD MRI | BOSTON SCIENTIFIC CORPORATION |
10/22/2025 |
|
P130008
S130 |
Normal 180 Day Track No User Fee |
Inspire® Upper Airway Stimulation | INSPIRE MEDICAL SYSTEMS | 10/22/2025 |
|
P130021
S178 |
30-Day Notice | Medtronic Evolut™ PRO+ Delivery Catheter System |
Medtronic, Inc. | 10/22/2025 |
|
P150012
S172 |
30-Day Notice | L110 ESSENTIO™ MRI SR,L111 ESSENTIO™ MRI DR,L131 ESSENTIO™ MRI EL DR,L210 PROPONENT,L211 PROPONENT,L231 PROPONENT,L310 A |
BOSTONSCIENTIFIC | 10/22/2025 |
|
P160013
S019 |
30-Day Notice | Organ Care System™ (OCS™) Lung System |
TransMedics, Inc | 10/22/2025 |
|
P180051
S008 |
30-Day Notice | Organ Care System™ (OCS™) Heart System |
TransMedics, Inc. | 10/22/2025 |
|
P190001
S002 |
Normal 180 Day Track | Therascreen® PIK3CA RGQ PCR Kit | QIAGEN GMBH | 10/22/2025 |
|
P200031
S011 |
30-Day Notice | Organ Care System™ (OCS™) Liver | TransMedics, Inc. | 10/22/2025 |
|
P220025
S007 |
Real-Time Process | LimFlow System | LimFlow, Inc. | 10/22/2025 |
|
P230036
S016 |
30-Day Notice | Esprit BTK RX System; Esprit BTK OTW System |
Abbott Medical | 10/22/2025 |
|
P230040
S023 |
30-Day Notice | Cordella Pulmonary Artery Sensor System (CorPASS) |
Endotronix, Inc. | 10/22/2025 |
|
P240040
S003 |
30-Day Notice | Oncomine Dx Express Test | Life Technologies Corporation |
10/22/2025 |
|
P960040
S510 |
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 | 10/22/2025 |
|
P960040
S511 |
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 I |
BOSTON SCIENTIFIC | 10/22/2025 |
|
P030047
S052 |
30-Day Notice | PRECISE® PRO Rx Nitinol Stent System; PRECISE® PRO Transcarotid Stent System |
Cordis US Corporation | 10/21/2025 |
|
P130008
S131 |
30-Day Notice | Inspire Upper Airway Stimulation | INSPIRE MEDICAL SYSTEMS | 10/21/2025 |
|
P140030
S021 |
Special (Immediate Track) |
Astron Peripheral Self- Expanding Nitinol Stent System |
BIOTRONIK, INC. | 10/21/2025 |
|
P160025
S022 |
Special (Immediate Track) |
Pulsar-18 T3 Stent System | BIOTRONIK, INC. | 10/21/2025 |
|
P240011
S002 |
30-Day Notice | Altaviva™ Implantable Neurostimulator |
Medtronic Neuromodulation |
10/21/2025 |
|
P030040
S024 |
Real-Time Process | Atellica IM Hepatitis B Core IgM (aHBcM) |
SIEMENS HEALTHCARE DIAGNOSTICS |
10/17/2025 |
|
P090024
S013 |
Real-Time Process | Atellica IM Hepatitis B E Antigen (HBeAg) |
SIEMENS HEALTHCARE DIAGNOSTICS |
10/17/2025 |
|
P100039
S018 |
Real-Time Process | Atellica IM Anti-Hepatitis B Surface Antigen 2 (aHBs2) |
SIEMENS HEALTHCARE DIAGNOSTICS INC. |
10/17/2025 |
|
P110041
S016 |
Normal 180 Day Track | Atellica IM Hepatitis B Surface Antigen II (HBsII) |
SIEMENS CORP. | 10/17/2025 |
|
P110041
S017 |
Real-Time Process | Atellica IM Hepatitis B Surface Antigen II (HBsII) & Atellica IM Hepatitis B Surface Antigen II Confirmatory |
SIEMENS CORP. | 10/17/2025 |
|
P150014
S056 |
Normal 180 Day Track | Cobas® HBV | Roche Molecular Systems, Inc. |
10/17/2025 |
|
P200013
S027 |
Real-Time Process | Alinity M HBV | Abbott Molecular, Inc. | 10/17/2025 |
|
P200017
S005 |
Real-Time Process | Atellica IM Anti-HBe2 (aHBe2) | Siemens Healthcare Diagnostics, Inc. |
10/17/2025 |
|
P210019
S004 |
Real-Time Process | Atellica IM HBc Total 2 (HBcT2) | Siemens Healthcare Diagnostics, Inc. |
10/17/2025 |
| P230015 | Original | Access HBsAg, Access HBsAg Confirmatory, Access HBsAg Calibrator, Access HBsAg QC |
Beckman Coulter, Inc. | 10/17/2025 |
|
P020025
S147 |
30-Day Notice | RHYTHMIA HDx™ Ablation Connection Box (for INTELLAGEN™) (M004RA65010); Rhythmia HDx™ Ablation Connection Box (Maestro™) |
BOSTON SCIENTIFIC | 10/17/2025 |
|
P040037
S171 |
30-Day Notice | GORE® VIABAHN® Endoprosthesis; GORE® VIABAHN® Endoprosthesis With Heparin Bioactive Surface |
W.L. GORE & ASSOCIATES,INC |
10/17/2025 |
|
P040038
S050 |
30-Day Notice | XACT Carotid Stent System (XACT CSS) And XACT Transcarotid Stent System (XACT TSS) |
ABBOTT VASCULAR INC. | 10/17/2025 |
|
P060040
S112 |
135 Review Track For 30-Day Notice |
HeartMate Apical Coring Knife | Abbott Medical | 10/17/2025 |
|
P100009
S081 |
30-Day Notice | MITRACLIP DELIVERY SYSTEM | Abbott Medical | 10/17/2025 |
|
P130006
S110 |
30-Day Notice | GORE® VIABAHN® Endoprosthesis And GORE® VIABAHN® Endoprosthesis With Heparin Bioactive Surface |
W.L. GORE & ASSOCIATES,INC |
10/17/2025 |
|
P150005
S091 |
30-Day Notice | RHYTHMIA HDx™ Ablation Connection Box (for INTELLAGEN™) (M004RA65010); Rhythmia HDx™ Ablation Connection Box (Maestro™) |
Boston Scientific Corp. | 10/17/2025 |
|
P160021
S049 |
30-Day Notice | GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis |
W. L. Gore & Associates, Inc. |
10/17/2025 |
|
P210032
S024 |
30-Day Notice | GORE® TAG® Thoracic Branch Endoprosthesis |
W. L. Gore & Associates, Inc. |
10/17/2025 |
|
P230003
S009 |
Real-Time Process | Alinity M HR HPV | Abbott Molecular, Inc | 10/17/2025 |
|
P230007
S018 |
30-Day Notice | TriClip G4 System | Abbott Medical | 10/17/2025 |
|
P240011
S001 |
30-Day Notice | Altaviva™ Implantable Neurostimulator |
Medtronic Neuromodulation |
10/17/2025 |
|
P920047
S138 |
30-Day Notice | RHYTHMIA HDx™ Ablation Connection Box (for INTELLAGEN™) (M004RA65010) |
Boston Scientific Corp. | 10/17/2025 |
|
P000009
S123 |
30-Day Notice | Ilivia Neo 7 DR-T 429529; Intica Neo 7 DR-T 429558; Intica Neo 5 DR-T 429568 |
BIOTRONIK, INC. | 10/16/2025 |
|
P010029
S042 |
30-Day Notice | EUFLEXXA® (1% SODIUM HYALURONATE) | FERRING PHARMACEUTICALS, INC. |
10/16/2025 |
|
P050023
S203 |
30-Day Notice | Ilivia 7 VR-T DX 404624; Intica 7 VR-T DX 404633; Intica 5 VR-T DX 404688; Ilivia 7 VR-T 404625; Intica 7 VR-T 404634; I |
BIOTRONIK, INC. | 10/16/2025 |
|
P070008
S171 |
30-Day Notice | Edora 8 HF-T QP 407137 Edora 8 HF-T 407138 Evity 8 HF-T QP 407139 Evity 8 HF-T 407140 Enitra 8 HF-T QP 407141 Enitra 8 H |
BIOTRONIK, INC. | 10/16/2025 |
|
P080025
S333 |
30-Day Notice | InterStim® Therapy System, Verify® Evaluation System |
MEDTRONIC NEUROMODULATION |
10/16/2025 |
|
P110016
S089 |
Normal 180 Day Track No User Fee |
FlexAbility™ Ablation Catheter, Sensor Enabled™ |
Abbott Medical | 10/16/2025 |
|
P130016
S058 |
Real-Time Process | Nucleus® Hybrid™ L24 Cochlear Implant System |
Cochlear Americas | 10/16/2025 |
|
P140031
S195 |
30-Day Notice | Edwards SAPIEN 3 Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra RES |
EDWARDS LIFESCIENCES, LLC. |
10/16/2025 |
|
P150001
S110 |
30-Day Notice | Medtronic MiniMed 630G System | MEDTRONIC MINIMED | 10/16/2025 |
|
P150036
S078 |
30-Day Notice | EDWARDS INTUITY Elite Valve | EDWARDS LIFESCIENCES, LLC. |
10/16/2025 |
|
P150040
S023 |
30-Day Notice | VISUMAX 800 Femtosecond Laser | Carl Zeiss Meditec, Inc. | 10/16/2025 |
|
P150048
S093 |
30-Day Notice | INSPIRIS RESILIA Aortic Valve; MITRIS RESILIA Mitral Valve |
EDWARDS LIFESCIENCES, LLC. |
10/16/2025 |
|
P160007
S056 |
30-Day Notice | Guardian Connect System Simplera System |
MEDTRONIC MINIMED | 10/16/2025 |
|
P160017
S130 |
30-Day Notice | MiniMed 670G System; MiniMed 770G System; MiniMed 780G System |
MEDTRONIC MINIMED, INC. | 10/16/2025 |
|
P200015
S071 |
30-Day Notice | Edwards SAPIEN 3 Transcatheter Heart Valve |
Edwards Lifesciences, LLC |
10/16/2025 |
|
P210006
S014 |
30-Day Notice | Thoraflex™ Hybrid | Vascutek Ltd. | 10/16/2025 |
|
P250012
S004 |
30-Day Notice | Simplera Sync Sensor, Guardian 4 Sensor |
Medtronic MiniMed Inc. | 10/16/2025 |
|
P840001
S611 |
30-Day Notice | Restore, Itrel®, Synergy IntellisTM, VantaTM And InceptivTM Spinal Cord Stimulation Systems And PiscesTM, Specify®, And |
MEDTRONIC NEUROMODULATION |
10/16/2025 |
|
P860004
S452 |
30-Day Notice | SynchroMed™ Infusion System, Ascenda™ Intrathecal Catheters |
MEDTRONIC Inc. | 10/16/2025 |
|
P860057
S223 |
30-Day Notice | Carpentier-Edwards PERIMOUNT RSR Pericardial Aortic Bioprosthesis; Carpentier-Edwards PERIMOUNT Plus Mitral Bioprosthesi |
EDWARDS LIFESCIENCES, LLC. |
10/16/2025 |
|
P950037
S278 |
30-Day Notice | Edora 8 DR-T 407145, Evity 8 DR-T 407146, Enitra 8 DR-T 407147, Enticos 8 DR-T 407148, Evity 6 DR-T 407149, Enitra 6 DR- |
BIOTRONIK, INC. | 10/16/2025 |
|
P960009
S522 |
30-Day Notice | Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ |
MEDTRONIC Inc. | 10/16/2025 |
|
P970004
S438 |
30-Day Notice | InterStim® Therapy System, Verify® Evaluation System |
MEDTRONIC NEUROMODULATION |
10/16/2025 |
|
P970051
S236 |
Real-Time Process | Nucleus® 24 Cochlear Implant System | Cochlear Americas | 10/16/2025 |
|
P980023
S139 |
30-Day Notice | Ilivia Neo 7 VR-T DX 429530; Intica Neo 7 VR-T DX 429559; Intica Neo 5 VR-T DX 429569 |
BIOTRONIK, INC. | 10/16/2025 |
|
P000046
S031 |
30-Day Notice | Ophthalin; Nuvisc; Anikavisc | Anika Therapeutics, Inc. | 10/15/2025 |
|
P040043
S147 |
30-Day Notice | GORE® TAG® Conformable Thoracic Endoprosthesis |
W. L. GORE & ASSOCIATES, INC. |
10/15/2025 |
|
P190023
S028 |
30-Day Notice | FlexNav Delivery System; Navitor Transcatheter Aortic Valves |
Abbott Medical | 10/15/2025 |
|
P240040
S002 |
Normal 180 Day Track No User Fee |
Oncomine Dx Express Test | Life Technologies Corporation |
10/15/2025 |
|
P810002
S125 |
30-Day Notice | Masters Series Mechanical Heart Valve |
Abbott Medical | 10/15/2025 |
|
BP953200
S129 |
Normal 180 Day Track | Apligraf | Organogenesis, Inc. | 10/14/2025 |
|
P160026
S062 |
30-Day Notice | LIFEPAK 1000 Defibrillator | Physio-Control. Inc. | 10/14/2025 |
|
P200039
S018 |
30-Day Notice | Shockwave™ Lntravascular Lithotripsy {IVL) System With Shockwave C2/ C2+/ C2 Aero Coronary IVL Catheter |
Shockwave Medical, Inc. | 10/14/2025 |
|
P960058
S172 |
30-Day Notice | HiResolution™ Bionic Ear System | ADVANCED BIONICS | 10/14/2025 |
|
P070001
S025 |
Panel Track | Prodisc C SK And Prodisc C Vivo | Centinel Spine, LLC | 10/10/2025 |
|
P180038
S025 |
Real-Time Process | LIAISON® XL Murex Anti-HBc And LIAISON® XL MUREX Control Anti-hbc |
DiaSorin Inc. | 10/10/2025 |
|
P180039
S023 |
Real-Time Process | LIAISON® XL Murex Anti-HBs, LIAISON® XL MUREX Control Anti-HBs And LIAISON® XL Murex Anti-HBs Verifier |
DiaSorin Inc. | 10/10/2025 |
|
P180045
S020 |
Real-Time Process | LIAISON® XL MUREX HBc IgM And LIAISON® XL MUREX Control HBc IgM |
DiaSorin Inc. | 10/10/2025 |
|
P180048
S021 |
Real-Time Process | LIAISON® XL MUREX HBeAg And LIAISON® XL MUREX Control HBeAg |
DiaSorin Inc. | 10/10/2025 |
|
P180049
S021 |
Real-Time Process | LIAISON® XL MUREX Anti-HBe And LIAISON® XL MUREX Control Anti-HBe |
DiaSorin Inc. | 10/10/2025 |
|
P190017
S026 |
Real-Time Process | LIAISON® XL MUREX HBsAg Qual And LIAISON® XL MUREX Control HBsAg Qual |
DiaSorin Inc | 10/10/2025 |
|
P090016
S066 |
Normal 180 Day Track | Belotero Balance (+) Lidocaine Dermal Filler |
MERZ NORTH AMERICA, INC | 10/10/2025 |
|
P110038
S033 |
Normal 180 Day Track No User Fee |
RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM |
BOLTON MEDICAL, INC. | 10/10/2025 |
|
P140031
S194 |
Normal 180 Day Track No User Fee |
SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES |
EDWARDS LIFESCIENCES, LLC. |
10/10/2025 |
|
P170030
S056 |
135 Review Track For 30-Day Notice |
Orsiro Mission Sirolimus Eluting Coronary Stent System |
Biotronik, Inc | 10/10/2025 |
|
P180047
S037 |
Real-Time Process | LIAISON® QuantiFERON® - TB Gold Plus And LIAISON® XL Control QuantiFERON-TB Gold Plus |
DiaSorin, Inc. | 10/10/2025 |
|
P200028
S026 |
Normal 180 Day Track No User Fee |
DiamondTemp Ablation System | Medtronic Inc. | 10/10/2025 |
|
P220014
S009 |
Real-Time Process | CraniSeal Dural Sealant | Pramand, LLC | 10/10/2025 |
|
P220034
S007 |
Real-Time Process | LIAISON® Biotrin Parvovirus B19 IgG Plus, LIAISON® Biotrin Control Parvovirus B19 IgG Plus |
DiaSorin, Inc. | 10/10/2025 |
| BP251179 | Original | Device Name: N/A | bioLytical Laboratories, Inc |
10/09/2025 |
|
N12159
S126 |
30-Day Notice | SURGICEL ORIGINAL 2INX14IN (5.1CMX35.6CM); SURGICEL ORIGINAL 4INX8IN (10.2CMX20.3CM); SURGICEL ORIGINAL 2INX3IN(5.1CMX7. |
ETHICON, INC. | 10/09/2025 |
|
P020004
S204 |
30-Day Notice | GORE® EXCLUDER® AAA Endoprosthesis And Iliac Branch Endoprosthesis |
W.L. GORE & ASSOCIATES,INC |
10/09/2025 |
|
P030036
S154 |
30-Day Notice | MEDTRONIC SELECTSECURE LEAD MODEL 3830 |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
10/09/2025 |
|
P060011
S039 |
Panel Track | RayOne EMV Toric | RAYNER INTRAOCULAR LENSES LTD. |
10/09/2025 |
|
P160007
S054 |
Normal 180 Day Track No User Fee |
Guardian Connect System | MEDTRONIC MINIMED | 10/09/2025 |
|
P160017
S127 |
Normal 180 Day Track No User Fee |
MiniMed 780G System | MEDTRONIC MINIMED, INC. | 10/09/2025 |
|
P160050
S010 |
Normal 180 Day Track | Barricaid® Annular Closure Device | INTRINSIC THERAPEUTICS | 10/09/2025 |
|
P160054
S113 |
30-Day Notice | HeartMate 3 Left Ventricular Assist System |
Abbott Medical | 10/09/2025 |
|
P220021
S006 |
Normal 180 Day Track No User Fee |
DETOUR System | Endologix, LLC | 10/09/2025 |
|
P250012
S002 |
Normal 180 Day Track No User Fee |
Guardian 4 Sensor | Medtronic MiniMed Inc. | 10/09/2025 |
|
P880047
S067 |
30-Day Notice | GYNECARE INTERCEED 3INX4IN(7.6CMX10.2CM); GYNECARE INTERCEED 5INX6IN(12.7CMX15.2CM); GYNECARE INTERCEED 3INX2IN(7.6CMX5. |
ETHICON, INC. | 10/09/2025 |
|
P010015
S573 |
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. | 10/08/2025 |
|
P100049
S038 |
Normal 180 Day Track No User Fee |
LINX Reflux Management System | TORAX MEDICAL | 10/08/2025 |
|
P160055
S052 |
Real-Time Process | Light Adjustable Lens And Light Delivery Device |
RxSight, Inc. | 10/08/2025 |
|
P230017
S008 |
30-Day Notice | PulseSelect™ Pulsed Field Ablation (PFA) System |
Medtronic, Inc. | 10/08/2025 |
