| ESSENTIO MRI (Model L131); PROPONENT MRI (Model L231); ACCOLADE MRI (Model L331); ESSENTIO MRI (Models L110, L111); PRO |
PMA |
Boston Scientific |
LWP |
2026-10-03 |
| ALTRUA 2 (Model S722); ESSENTIO (Model L121); PROPONENT (Model L221); ACCOLADE (Model L321); ALTRUA 2 (Models S701, |
PMA |
Boston Scientific Corp |
LWP |
2026-10-03 |
| VALITUDE (Model U125); VALITUDE X4 (Model U128); VISIONIST (Models U225, U226); VISIONIST X4 (Model U228) |
PMA |
Guidant Corp. |
NKE |
2026-10-03 |
| CentriMag Circulatory Support System |
PMA |
Abbott |
DSQ |
2026-10-02 |
| FARAPULSE Pulsed Field Ablation System (FARAWAVE Pulsed Field Ablation Catheter, FARASTAR Catheter Connection Cable, |
PMA |
Farapulse, Inc. |
QZI |
2026-10-02 |
| Motiva SmoothSilk Round Ergonomix Silicone Gel-Filled Breast Implants, Motiva SmoothSilk Round Silicone Gel-Filled Breas |
PMA |
Motiva USA, LLC |
FTR |
2026-10-02 |
| VNS Therapy® System |
PMA |
LivaNova USA, Inc. |
LYJ |
2026-10-02 |
| Sphere-9 Catheter and Affera Ablation System |
PMA |
Medtronic, Inc. |
QZI |
2026-10-02 |
| EMBLEM Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) high voltage (HV) Capacitor |
PMA |
Boston Scientific Corporation |
LWS |
2026-10-02 |
| MediBeacon Transdermal GFR System |
PMA |
Medibeacon, Inc. |
SDK |
2026-10-02 |
| X Series®, R Series®, AED Pro®, AED 3 BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower |
PMA |
ZOLL Medical Corporation |
MKJ |
2026-10-02 |
| VISCOAT Ophthalmic Viscosurgical Device; DUOVISC Ophthalmic Viscosurgical System; DISCOVISC Ophthalmic Viscosurgical |
PMA |
Alcon Laboratories |
LZP |
2026-10-01 |
| CraniSeal Dural Sealant |
PMA |
Pramand, LLC |
NQR |
2026-10-01 |
| HeartMate II LVAS |
PMA |
ABBOTT MEDICAL |
DSQ |
2026-10-01 |
| EXCOR Pediatric Ventricular Assist Device |
PMA |
Berlin Heart, Inc. |
DSQ |
2026-10-01 |
| PROVISC Ophthalmic Viscosurgical Device |
PMA |
Alcon Research, Ltd. |
LZP |
2026-10-01 |
| HeartMate 3 LVAS |
PMA |
ABBOTT MEDICAL |
DSQ |
2026-10-01 |
| Glaukos® iStent inject® W Trabecular Micro-Bypass System, Glaukos® iStent inject® W Trabecular Micro-Bypass System with |
PMA |
Glaukos Corporation |
OGO |
2026-10-01 |
| Autus Size-Adjustable Valve |
PMA |
Edwards Lifesciences, LLC |
SJL |
2026-10-01 |
| XIENCE PRO5 Everolimus Eluting Coronary Stent System (XIENCE PRO5), XIENCE Skypoint Everolimus Eluting Coronary Stent Sy |
PMA |
Abbott Vascular |
NIQ |
2026-10-01 |
| UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System |
PMA |
Alcon Research, LLC |
LPO |
2026-09-30 |
| Harmony TPV System |
PMA |
Medtronic, Inc. |
NPV |
2026-09-30 |
| enVista® Hydrophobic Acrylic Intraocular Lens |
PMA |
Bausch & Lomb, Inc. |
HQL |
2026-09-30 |
| enVista Envy Hydrophobic Acrylic Intraocular Lens |
PMA |
Bausch & Lomb, Inc. |
MFK |
2026-09-30 |
| UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System |
PMA |
Alcon Research, LLC |
LPO |
2026-09-30 |