| SCULPTRA (injectable poly-L Lactic acid) and SCULPTRA Aesthetic (injectable poly-L Lactic acid) (P030050/S032) | Q-Med AB | 2021-05-18 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S473) | Medtronic, Inc. | 2021-05-18 |
| LifeVest Wearable Defibrillator (P010030/S148) | Zoll Manufacturing Corporation | 2021-05-17 |
| WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System (P130013/S044) | Boston Scientific Corp | 2021-05-17 |
| LifeVest Wearable Defibrillator (P010030/S149) | Zoll Manufacturing Corporation | 2021-05-17 |
| Bellafill Dermal Filler (P020012/S038) | Tiger Aesthetics Medical, LLC | 2021-05-14 |
| ARCHITECT CORE-M Reagent Kit, Alinity i Anti-HBc IgM Reagent Kit (P060035/S031) | Abbott Laboratories | 2021-05-14 |
| ThinPrep Genesis Processor (P950039/S040) | Hologic, Inc. | 2021-05-14 |
| TheraSphere (P200029/S001) | Boston Scientific Corporation | 2021-05-14 |
| Arctic Front Advance Cardiac CryoAblation Catheters (P100010/S115) | Medtronic Cryocath, LP | 2021-05-13 |
| SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System (P140031/S125) | Edwards Lifesciences, LLC | 2021-05-13 |
| XIENCE Skypoint Everolimus Eluting Coronary Stent System (P110019/S113) | Abbott Vascular | 2021-05-13 |
| Wave Writer Alpha Spinal Cord Stimulator (SCS) System (P030017/S345) | Boston Scientific Corp | 2021-05-13 |
| THERMOCOOL SMARTTOUCH SF Catheter (P030031/S118) | Biosense Webster, Inc. | 2021-05-13 |
| Zeiss 3-piece Hydrophobic Acrylic Intraocular lens (IOL) (P100016/S007) | Carl Zeiss Meditec Production, LLC | 2021-05-13 |
| Vercise Genus Deep Brain Stimulation (DBS) System (P150031/S042) | Boston Scientific Corp | 2021-05-13 |
| Supera Peripheral Stent System (P120020/S026) | Abbott Vascular (Idef Technologies Inc) | 2021-05-12 |
| Promus Premier and Promus Elite Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S192) | Boston Scientific Corp | 2021-05-12 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S042) | Boston Scientific Corp | 2021-05-12 |
| EnVeo R, EnVeo PRO and Evolut PRO+ Delivery Catheter Systems (P130021/S090) | Medtronic, Inc. | 2021-05-11 |
| Integrity Coronary Stent System (hereafter called Integrity) (P030009/S102) | Medtronic, Ireland | 2021-05-11 |
| Falope-Ring® Band and Applicator Systems (P870076/S026) | Gyrus Acmi, Inc. | 2021-05-11 |
| ELCA Coronary Atherectomy Catheter (P910001/S113) | Spectranetics Corp. | 2021-05-11 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System (hereafter called Resolute Onyx) (P160043/S046) | Medtronic Vascular | 2021-05-11 |
| Resolute Integrity Zotarolimus Eluting Coronary Stent Systems (hereafter called Resolute Integrity) (P110013/S110) | Medtronic Vascular | 2021-05-11 |
| CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL (P010012/S538) | Boston Scientific Corp | 2021-05-10 |
| VENTAK(R) P2 SYSTEM (P930035/S032) | Boston Scientific | 2021-05-10 |
| LCS Total Knee System (P830055/S265) | Depuy, Inc. | 2021-05-10 |
| IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD (P150012/S111) | Boston Scientific | 2021-05-10 |
| THINLINE ENDOCARDIAL PACING LEADS (P960004/S094) | Boston Scientific | 2021-05-10 |
| VENTAK AND AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS (P830060/S086) | Boston Scientific | 2021-05-10 |
| VENTAK(R) PRX (TM) MODEL 1700,1705 PULSE GENERATOR (P910077/S184) | Boston Scientific | 2021-05-10 |
| Senza Spinal Cord Stimulation (SCS) System (P130022/S041) | Nevro Corporation | 2021-05-10 |
| SWEET TIP(R) RX STEROID ELUTING LEAD (P960006/S052) | Boston Scientific | 2021-05-10 |
| ENDOTAK LEAD SYSTEM (P910073/S161) | Boston Scientific | 2021-05-10 |
| PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE (N970003/S264) | Boston Scientific Corp | 2021-05-10 |
| Senza Spinal Cord Stimulation System (SCS) (P130022/S040) | Nevro Corporation | 2021-05-10 |
| EverFlex Self-Expanding Peripheral Stent System, EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System (P110023/S032) | Medtronic Vascular, Inc. | 2021-05-07 |
| Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S038) | Pfizer, Inc. | 2021-05-07 |
| NeuroPace RNS System (P100026/S086) | NeuroPace, Inc. | 2021-05-07 |
| Protégé RX Self-expanding Stent System, Protégé GPS Self-Expanding Peripheral Stent System (P060001/S032) | Medtronic Vascular, Inc. | 2021-05-07 |
| Revanesse Lips+ 1.2 mL (P160042/S014) | Prollenium Medical Technologies, Inc. | 2021-05-07 |
| lntraStent DoubleStrut Stent, Visi-Pro Balloon-Expandable Peripheral Stent System (P030045/S006) | Medtronic Vascular, Inc. | 2021-05-07 |
| Abre Venous Self-expanding Stent System (P200026/S001) | Medtronic Vascular, Inc. | 2021-05-07 |
| iSert® Pre-loaded System, iSert Preloaded IOL System, IPURE Pre-loaded System, PreVue Pre-loaded System (P080004/S040) | Hoya Surgical Optics, Inc. | 2021-05-07 |
| Medtronic Deep Brain Stimulation Therapy System (P960009/S397) | Medtronic, Inc. | 2021-05-07 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CR T-D (P010031/S744) | Medtronic Cardiac Rhythm Disease Management | 2021-05-06 |
| Orsiro Sirolimus Eluting Coronary Stent System (P170030/S016) | Biotronik AG | 2021-05-06 |
| ACUVUE® Abiliti Overnight and ACUVUE® Abiliti Overnight Therapeutic Lenses for Myopia Management (P990018/S006) | Menicon Co, Ltd. | 2021-05-06 |
| ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, ACCOLADE MRI EL DR (P150012/S110) | Boston Scientific | 2021-05-06 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S782) | Medtronic Cardiac Rhythm Disease Management | 2021-05-06 |
| Biofinity Toric Multifocal (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S127) | CooperVision, Inc. | 2021-05-06 |
| PRO-Kinetic Energy Coronary Stent System (P160003/S013) | Biotronik AG | 2021-05-06 |
| ORIGEN MINI ICD VR, ORIGEN MINI ICD DR, INOGEN MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN MINI ICD VR, DYNAGEN MINI ICD DR (P960040/S464) | Boston Scientific | 2021-05-06 |
| VALITUDE CRT-P, VALITUDE X4 CRT-P, VISIONIST CRT-P, VISIONIST X4 CRT-P (P030005/S209) | Guidant Corp. | 2021-05-06 |
| ESSENTIO SR, ESSENTIO DR, ESSENTIO EL DR, PROPONENT SR, PROPONENT DR, PROPONENT EL DR, ACCOLADE SR, ACCOLADE DR, ACCOLAD (N970003/S263) | Boston Scientific Corp | 2021-05-06 |
| Astron Peripheral Self- Expanding Nitinol Stent System (P140030/S013) | Biotronik AG | 2021-05-06 |
| ORIGEN CRT-D, ORIGEN X4 CRT-D, MOMENTUM CRT-D, MOMENTUM, MOMENTUM X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, DYNAGEN CRT-D (P010012/S537) | Boston Scientific Corp | 2021-05-06 |
| Itrel®, Synergy® and lntellisTM Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris® (P840001/S487) | Medtronic Neuromodulation | 2021-05-06 |
| Astron Pulsar Stent System (P160025/S011) | Biotronik AG | 2021-05-06 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Intrinsic 30 ICD, (P980016/S774) | Medtronic Cardiac Rhythm Disease Management | 2021-05-05 |
| Micra AV TPS and Micra TPS (P150033/S095) | Medtronic, Inc. | 2021-05-05 |
| CERAMAX Ceramic Total Hip System (P070026/S081) | DePuy Orthopaedics, Inc. | 2021-05-05 |
| Consulta CRT-P, Syncra CRT-P, Viva CRT-P (P010015/S469) | Medtronic, Inc. | 2021-05-05 |
| LCS Total Knee System (P830055/S266) | Depuy, Inc. | 2021-05-05 |
| Mobi-C® Cervical Disc Prosthesis Two-Level (P110009/S030) | Highridge Medical, LLC | 2021-05-05 |
| Mobi-C® Cervical Disc Prosthesis One-Level (P110002/S030) | Highridge Medical, LLC | 2021-05-05 |
| ENROUTE® Transcarotid Stent System (P140026/S018) | Boston Scientific Corporation | 2021-05-05 |
| 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 (P010031/S736) | Medtronic Cardiac Rhythm Disease Management | 2021-05-05 |
| MyCareLink Patient Monitor (P890003/S443) | Medtronic, Inc. | 2021-05-05 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, (P980035/S676) | Medtronic, Inc. | 2021-05-05 |
| GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System (P040043/S128) | W. L. Gore & Associates, Inc. | 2021-05-04 |
| Conformable GORE TAG Thoracic Endoprosthesis (P040043/S127) | W. L. Gore & Associates, Inc. | 2021-05-04 |
| Therapy Cool Path Duo Ablation Catheter, Therapy Cool Flex Ablation Catheter (P110016/S075) | ABBOTT MEDICAL | 2021-05-04 |
| Akreos Posterior Chamber Intraocular Lens (P060022/S026) | Bausch & Lomb, Inc. | 2021-05-04 |
| TECNIS Simplicity Delivery System (P980040/S134) | Johnson & Johnson Surgical Vision, Inc. | 2021-05-04 |
| Implantable System for Remodulin (P140032/S070) | Medtronic, Inc. | 2021-05-04 |
| Therapy Cool Path Ablation Catheter (P060019/S052) | Irvine Biomedical, Inc. | 2021-05-04 |
| SynchroMed® Infusion System (P860004/S373) | Medtronic, Inc. | 2021-05-04 |
| Therapy Ablation Catheter, Therapy 4MM Thermistor Ablation Catheter, Therapy Bi-Directional Ablation Catheter (P040014/S044) | Irvine Biomedical, Inc. | 2021-05-04 |
| Safire TX Ablation Catheter, Therapy Dual 8 Ablation Catheter, Therapy 8MM Thermistor Ablation Catheter (P040042/S050) | Irvine Biomedical,Inc.(Ibi) | 2021-05-04 |
| SynchroMed Infusion System, Ascenda® IntrathecaI Catheters (P860004/S372) | Medtronic, Inc. | 2021-05-03 |
| Implantable System for Remodulin (P140032/S069) | Medtronic, Inc. | 2021-05-03 |
| DEFLUX Injectable Gel (P000029/S087) | Palette Life Sciences | 2021-05-03 |
| Solesta Injectable Gel (P100014/S024) | Palette Life Sciences | 2021-05-03 |
| Express LD Iliac Premounted Stent System (P090003/S051) | Boston Scientific Corporation | 2021-04-30 |
| SICD Gen 2, SICD MRI (P110042/S156) | Boston Scientific Corporation | 2021-04-30 |
| PSW 2100.U and NEO 2100.U (P980023/S105) | Biotronik, Inc. | 2021-04-30 |
| SURGIFOAM® Absorbable Gelatin Sponge, U.S.P., Hemorrhoidectomy Sponge/Oral Sponge and SURGIFOAM® Absorbable Gelatin Powd (P990004/S047) | Ferrosan Meidcal Devices A/S | 2021-04-30 |
| ORIGEN CRT-D, ORIGEN X4 CRT-D, MOMENTUM CRT-D, MOMENTUM, MOMENTUM X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, DYNAGEN CRT-D (P010012/S536) | Boston Scientific Corp | 2021-04-30 |
| CERAMAX Ceramic Total Hip System (P070026/S080) | DePuy Orthopaedics, Inc. | 2021-04-30 |
| PSW 2100.U and NEO 2100.U (P050023/S154) | Biotronik, Inc. | 2021-04-30 |
| ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, ACCOLADE MRI EL DR (P150012/S109) | Boston Scientific | 2021-04-30 |
| ORIGEN MINI ICD VR, ORIGEN MINI ICD DR, INOGEN MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN MINI ICD VR, DYNAGEN MINI ICD DR (P960040/S463) | Boston Scientific | 2021-04-30 |
| ESSENTIO SR, ESSENTIO DR, ESSENTIO EL DR, PROPONENT SR, PROPONENT DR, PROPONENT EL DR, ACCOLADE SR, ACCOLADE DR, ACCOLAD (N970003/S262) | Boston Scientific Corp | 2021-04-30 |
| RHA 2, RHA 3, RHA 4 Dermal Fillers (P170002/S016) | Teoxane S.A. | 2021-04-30 |
| VALITUDE CRT-P, VALITUDE X4 CRT-P, VISIONIST CRT-P, VISIONIST X4 CRT-P (P030005/S208) | Guidant Corp. | 2021-04-30 |
| PSW 2100.U and NEO 2100.U (P000009/S090) | Biotronik, Inc. | 2021-04-30 |
| PSW 2100.U and NEO 2100.U (P950037/S220) | Biotronik, Inc. | 2021-04-30 |
| PSW 2100.U and NEO 2100.U (P070008/S122) | Biotronik, Inc. | 2021-04-30 |