| ADVISA SR MRI A3SR01; IMPLANTABLE PULSE GENERATOR, DR MRI A2DR01 IMPLANTABLE PULSE GENERATOR, SOFTWARE MODEL 9995 (P980035/S374) | Medtronic, Inc. | 2015-03-19 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S498) | Medtronic Cardiac Rhythm Disease Management | 2015-03-19 |
| EZ STEER AND THERMOCOOL CATHETER FAMILIES (P030031/S066) | Biosense Webster, Inc. | 2015-03-19 |
| ENDOTAK RELIANCE S, ENDOTAK RELIANCE G/SG, ENDOTAK RELIANCE 4-SITE LEAD FAMILY (P910073/S129) | Boston Scientific | 2015-03-19 |
| DIAMONDBACK 360 CORONARY ORIBITAL ATHERECTOMY SYSTEMS (OAS) (P130005/S006) | Cardiovascular Systems, Inc. | 2015-03-18 |
| THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATIONAL CATHETER (P030031/S065) | Biosense Webster, Inc. | 2015-03-18 |
| THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATIONAL CATHETER (P040036/S048) | Biosense Webster, Inc. | 2015-03-18 |
| NIRXCELL COCR CORONARY STENT ON RX (P110004/S011) | Medinol, Ltd. | 2015-03-17 |
| EVERA S DR,EVERA S VR,EVERA XT DR,EVERA XT VR ICDS (P980016/S533) | Medtronic Cardiac Rhythm Disease Management | 2015-03-17 |
| PARADYM VR 8750, PARADYM DR 8750, PARADYM RF VR 9750, PARADYM RF DR 9750 (ZL102), INTENSIA VR ICD, INTENSIA DR (P980049/S106) | MicroPort CRM USA, Inc. | 2015-03-17 |
| REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR (P950029/S103) | MicroPort CRM USA, Inc. | 2015-03-17 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S497) | Medtronic Cardiac Rhythm Disease Management | 2015-03-17 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, (P980016/S531) | Medtronic Cardiac Rhythm Disease Management | 2015-03-17 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S010) | Boston Scientific Corp | 2015-03-17 |
| ION (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S114) | Boston Scientific Corp | 2015-03-17 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S103) | Boston Scientific Corp | 2015-03-17 |
| PARADYM CRT-D 8750, PARADYM RF CRT-D 9750 (ZL 102), INTENSIA CRT-D (P060027/S073) | MicroPort CRM USA, Inc. | 2015-03-17 |
| EXPRESS SD RENAL PREMOUNTED STENT SYSTEM (P060006/S066) | Boston Scientific Corp | 2015-03-17 |
| BRAVA , BRAVA QUAD/S , VIVA QUAD S/XT ,, VIVA S/XT CRT-D'S (P010031/S495) | Medtronic Cardiac Rhythm Disease Management | 2015-03-17 |
| WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (P130013) | Boston Scientific Corp | 2015-03-13 |
| EMBLEM S ICD SYSTEM (P110042/S043) | Boston Scientific Corporation | 2015-03-13 |
| PARADYM (VR/DR) 8750, PARADYM RF VR 9750, PARADYM RF DR 9750 (ZL101), PARADYM RF (VR/DR) 9750,INTENSIA (VR 124/DR 154) (P980049/S107) | MicroPort CRM USA, Inc. | 2015-03-13 |
| PARADYM CRT-D 8750, PARADYM RF CRT-D9750 (ZL101), PARADYM RF CRT-D9750 (ZL102), INTENSIA CRT-D 174 (P060027/S074) | MicroPort CRM USA, Inc. | 2015-03-13 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D (P010031/S496) | Medtronic Cardiac Rhythm Disease Management | 2015-03-11 |
| VASCADE VASCULAR CLOSURE SYSTEM (P120016/S009) | Cardiva Medical, Inc. | 2015-03-11 |
| CAPSUREFIX NOVUS LEAD (P930039/S126) | Medtronic, Inc. | 2015-03-11 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD AND EVERA XT VR ICD (P980016/S532) | Medtronic Cardiac Rhythm Disease Management | 2015-03-11 |
| ATTAIN STARFIX LEAD (P060039/S065) | Medtronic, Inc. | 2015-03-11 |
| CAPSUREFIX MRI LEAD (P090013/S178) | Medtronic, Inc. | 2015-03-11 |
| EXPRESS LD ILIAC PREMOUNTEDSTENT SYSTEM (P090003/S038) | Boston Scientific Corporation | 2015-03-06 |
| RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM (P110038/S009) | Bolton Medical, Inc. | 2015-03-06 |
| SUPERA PERIPHERAL STENT SYSTEM (P120020/S007) | Abbott Vascular (Idef Technologies Inc) | 2015-03-06 |
| RESQCPR SYSTEM (P110024) | ZOLL Medical Corporation | 2015-03-06 |
| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S030) | Boston Scientific Corp | 2015-03-06 |
| EXPRESS SD RENAL PREMOUNTED STENT SYSTEM (P060006/S065) | Boston Scientific Corp | 2015-03-06 |
| ATAKR RADIOFREQUENCY CATHETER ABLATION (RFCA) SYSTEMS. (P930029/S048) | Medtronic, Inc. | 2015-03-05 |
| RF CONTACTR (P930029/S047) | Medtronic, Inc. | 2015-03-05 |
| EVERA S(DR/VR) ICD, EVERA XT (DR/VR) ICD, MAXIMO II ICD, PROTECTA (XT)ICD,SECURA ICD, VIRTUOUSO II(DR/VR) ICD (P980016/S526) | Medtronic Cardiac Rhythm Disease Management | 2015-03-04 |
| ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG (P980035/S411) | Medtronic, Inc. | 2015-03-04 |
| BRAVA (CRT-D/QUAD),CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D,PROTECTA XT,VIVA QUAD (S/XT),VIVA (S/XT) (P010031/S490) | Medtronic Cardiac Rhythm Disease Management | 2015-03-04 |
| REVO MRI IPG (P090013/S174) | Medtronic, Inc. | 2015-03-04 |
| CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P (P010015/S263) | Medtronic, Inc. | 2015-03-04 |
| MYNX ACE VASCULAR CLOSURE DEVICE (MYNX ACE) (P040044/S062) | Cordis US Corporation | 2015-03-03 |
| ADVISA DR IPG, ADVISA DR MRI IPG (P980035/S413) | Medtronic, Inc. | 2015-03-03 |
| CONSULTA, SYNCRA, VIVA CRT-PS (P010015/S265) | Medtronic, Inc. | 2015-03-03 |
| EVERA S DR, EVERA S VR, EVERA XT DR,EVERA XT VR, MAXIMO II, PROTECTA, PROTECTA XT, SECURA, VIRTUOSO II DR/VR ICDS (P980016/S528) | Medtronic Cardiac Rhythm Disease Management | 2015-03-03 |
| BRAVA,BRAVA QUAD, CONCERTO II, CONSULTA, MAXIMO II, PROTECTA, PROTECTA XT, VIVA QUAD S, VIVA QUAD XT, VIVA S, VIVA XT CR (P010031/S492) | Medtronic Cardiac Rhythm Disease Management | 2015-03-03 |
| SPRINT QUATTRO LEAD (P920015/S148) | Medtronic, Inc. | 2015-03-03 |
| CAPSUREFIX MRI LEAD (P090013/S177) | Medtronic, Inc. | 2015-03-02 |
| CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD,SUREFIX LEAD, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD, VITATRON CRYSTALLINE ACT (P930039/S125) | Medtronic, Inc. | 2015-03-02 |
| CAPSURE SENSE LEAD, CAPSURE SP NOVUS LEAD,VITATRON CRYSTALLINE LEAD,VITATRON EXCELLENCE PS+ LEAD (P830061/S118) | Medtronic Cardiac Rhythm Disease Management | 2015-03-02 |
| CAPSURE SP NOVUS LEAD,CAPSURE Z NOVUS LEAD (P850089/S113) | Medtronic Cardiac Rhythm Disease Management | 2015-03-02 |
| TRANSVENE CS/SVC LEAD (P980050/S098) | Medtronic, Inc. | 2015-03-02 |
| SELECTSECURE LEAD (P030036/S077) | Medtronic Cardiac Rhythm Disease Management | 2015-03-02 |
| CAPSURE VDD 2 LEAD (P890003/S327) | Medtronic, Inc. | 2015-03-02 |
| ATTAIN ABILITY LEAD AND ATTAIN QUADRIPOLAR LEAD (P080006/S076) | Medtronic, Inc. | 2015-03-02 |
| ATTAIN BIPOLAR OTW LEAD AND ATTAIN OTW LEAD (P010015/S267) | Medtronic, Inc. | 2015-03-02 |
| ATTAIN STARFIX LEAD (P060039/S066) | Medtronic, Inc. | 2015-03-02 |
| SPRINT QUATRO LEAD,SUBCUTANEOUS LEAD (P920015/S149) | Medtronic, Inc. | 2015-03-02 |
| EVERA S DR, EVERA S VR,EVERA XT DR, EVERA XT VR, MAXIMO II, PROTECTA, PROTECTA XT, SECURA, VIRTUOSO II DR/VR ICDS (P980016/S527) | Medtronic Cardiac Rhythm Disease Management | 2015-03-01 |
| BRAVA, BRAVA QUAD, CONCERTO II, CONSULTA, MAXIMO II, PROTECTA, PROTECTA XT, VIVA QUAD S, VIVA QUAD XT,VIVA S, VIVA XT CR (P010031/S491) | Medtronic Cardiac Rhythm Disease Management | 2015-03-01 |
| INOGEN, ORIGEN AND DYNAGEN CRT-DS (P010012/S385) | Boston Scientific Corp | 2015-03-01 |
| ADAPTA,VERSA,SENSIA IPGS, ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG (P980035/S412) | Medtronic, Inc. | 2015-03-01 |
| INOGEN, ORIGEN AND DYNAGEN ICDS (P960040/S343) | Boston Scientific | 2015-03-01 |
| REVO MRI IPG (P090013/S175) | Medtronic, Inc. | 2015-03-01 |
| CONSULTA CRT-P,SYNCRA CRT-P,VIVA CRT-P (P010015/S264) | Medtronic, Inc. | 2015-03-01 |
| BRAVA, BRAVA QUAD, VIVA QUAD, VIVA QUAD S, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S493) | Medtronic Cardiac Rhythm Disease Management | 2015-03-01 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S530) | Medtronic Cardiac Rhythm Disease Management | 2015-03-01 |
| CONSULTA CRT-P, SYNERA CRT-P, VIVA CRT-P (P010015/S262) | Medtronic, Inc. | 2015-02-27 |
| ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER (P100010/S046) | Medtronic Cryocath, LP | 2015-02-27 |
| ADAPTA VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG. (P980035/S410) | Medtronic, Inc. | 2015-02-27 |
| REVO MRI IPG (P090013/S173) | Medtronic, Inc. | 2015-02-27 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S064) | Edwards Lifesciences, LLC | 2015-02-27 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S027) | Edwards Lifesciences, LLC | 2015-02-27 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021/S051) | Edwards Lifesciences, LLC | 2015-02-27 |
| EVERA S DR & VR ICD, EVERA XT DR & VR ICD, MAXIMO II ICD, PROTECTA ICD & XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S525) | Medtronic Cardiac Rhythm Disease Management | 2015-02-27 |
| BRAVA CRT-D; BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTCA CRT-D & XT CRT-D, VIVA QUAD (P010031/S489) | Medtronic Cardiac Rhythm Disease Management | 2015-02-27 |
| BRAVA , QUAD , VIVA QUAD S CRT-D'S; VIVA QUAD S , QUAD XT, S VIVA S CRT-D'S (P010031/S486) | Medtronic Cardiac Rhythm Disease Management | 2015-02-26 |
| TACTICATH QUARTZ ABLATION CATHETER (P130026/S001) | St Jude Medical | 2015-02-26 |
| ZILVER PTX DRUG-ELUTING PERIPHERAL STENT (P100022/S012) | Cook Ireland, Ltd. | 2015-02-26 |
| FLEXABILITY ABLATION CATHETER (P110016/S015) | ABBOTT MEDICAL | 2015-02-26 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, (P980016/S522) | Medtronic Cardiac Rhythm Disease Management | 2015-02-26 |
| SESOLOG / DIALOG / REGENCY FAMILY OF PACEMAKERS (P880006/S092) | St. Jude Medical, Inc. | 2015-02-25 |
| INTUA, INVIVE, VALITUDE, & VALITUDE X4 CRT-P'S (P030005/S116) | Guidant Corp. | 2015-02-25 |
| QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-D'S (P030054/S281) | ABBOTT MEDICAL | 2015-02-25 |
| FRONTIER/FRONTIER II / ANTHEM FAMILY OF CRT-P'S (P030035/S131) | ABBOTT MEDICAL | 2015-02-25 |
| MICRONY FAMILY OF PACEMAKER (P970013/S063) | ABBOTT MEDICAL | 2015-02-25 |
| AFFINITY /INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS (P880086/S253) | ABBOTT MEDICAL | 2015-02-25 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S009) | Boston Scientific Corp | 2015-02-25 |
| ASCENDRA + DELIVERY SYSTEM (P130009/S025) | Edwards Lifesciences, LLC | 2015-02-25 |
| FORMIO, VITALIO, INGENIO, ADVANTIO, ACCOLADE, PROPONENT, ESSENTIO, & ALTRUA 2 PACEMAKERS (N970003/S170) | Boston Scientific Corp | 2015-02-25 |
| ELLIPSE/FORTIFY ASSURA FAMILY OF ICD'S (P910023/S352) | ABBOTT MEDICAL | 2015-02-25 |
| HANCOCK II PROCINE BIOPROSTHETIC HEART VALVE (P980043/S048) | Medtronic, Inc. | 2015-02-25 |
| MOSAIC PORCINE BIOPROSTHETIC HEART VALVE (P990064/S057) | Medtronic, Inc. | 2015-02-25 |
| BRAVA- BRAVA QUAD , CONCERTO II , CONSULTA , MAXIMO II, PROTECTA, PROTECTA XT,VIVA QUAD, QUAD S AND IX CRT-D'S (P010031/S487) | Medtronic Cardiac Rhythm Disease Management | 2015-02-23 |
| ADAPTA VERSA, SENSIA IPG ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG (P980035/S409) | Medtronic, Inc. | 2015-02-23 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, XT CRT-D, VIVA QUAD S (P010031/S488) | Medtronic Cardiac Rhythm Disease Management | 2015-02-23 |
| DYNAGEN,INOGEN, ORIGEN, PUNCTUA, ENERGEN, INCEPTA CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR, (P010012/S384) | Boston Scientific Corp | 2015-02-23 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D, VI (P010031/S494) | Medtronic Cardiac Rhythm Disease Management | 2015-02-23 |
| REVO MRI IPG (P090013/S172) | Medtronic, Inc. | 2015-02-23 |