| ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG (P980035/S394) | Medtronic, Inc. | 2014-09-25 |
| CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P (P010015/S250) | Medtronic, Inc. | 2014-09-25 |
| CAPSURE SENSE LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE LEAD, VITATRON EXCELLENCE PS+ LEAD (P830061/S115) | Medtronic Cardiac Rhythm Disease Management | 2014-09-24 |
| ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG RELIA IPG (P980035/S393) | Medtronic, Inc. | 2014-09-24 |
| ATTAIN STARFIX LEAD (P060039/S063) | Medtronic, Inc. | 2014-09-24 |
| RF CONTACTR, RF ENHANCR II, RF MARINR, RF MARINR UNIPOLAR, RF CONDUCTR CATHETERS (P930029/S046) | Medtronic, Inc. | 2014-09-24 |
| EVERA S DR/VR, EVERA XT DR/VR, MAXIMO II, PROTECTA, PROTECTA XT, SECURA , VIRUOSO II DR/VR ICD'S (P980016/S501) | Medtronic Cardiac Rhythm Disease Management | 2014-09-24 |
| MODEL 5348 SINGLE CHAMBER TEMPORARY PACEMAKER, MODEL 5388 DUAL CHAMBER TEMPORARY PACEMAKER (P820003/S131) | Medtronic Cardiac Rhythm Disease Management | 2014-09-24 |
| SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD, TRANSVENE CS/SVC LEAD (P920015/S140) | Medtronic, Inc. | 2014-09-24 |
| CAPSUREFIX MRI LEAD, REVO MRI IPG (P090013/S156) | Medtronic, Inc. | 2014-09-24 |
| CAPSUREFIX NOVUS LEAD (P930039/S117) | Medtronic, Inc. | 2014-09-24 |
| CAPSUREFIX MRI LEAD (P090013/S155) | Medtronic, Inc. | 2014-09-24 |
| EPICARDIAL PATCH LEAD (P900061/S131) | Medtronic Cardiac Rhythm Disease Management | 2014-09-24 |
| ATTAIN BIPOLAR OTW LEAD, ATTAIN OTW LEAD, CONSULTA CRT-P, SYNCRA CRT-P AND VIVA CRT-P (P010015/S249) | Medtronic, Inc. | 2014-09-24 |
| ATTAIN ABILITY LEAD, ATTAIN PERFORMA QUADRIPOLAR LEAD (P080006/S072) | Medtronic, Inc. | 2014-09-24 |
| SELECTSECURE LEAD (P030036/S074) | Medtronic Cardiac Rhythm Disease Management | 2014-09-24 |
| CAPSURE VDD2, CARELINK PROGRAMMER (P890003/S321) | Medtronic, Inc. | 2014-09-24 |
| TRANSVENE CS/SVC LEAD (P980050/S096) | Medtronic, Inc. | 2014-09-24 |
| CAPSUREFIX LEAD,CAPSUREFIX NOVUS LEAD,SUREFIX LEAD,VITATRON CRYSTALLINE ACTIVE FIXATION LEAD, TORQUE CLIP DEVICE-ACCESSO (P930039/S118) | Medtronic, Inc. | 2014-09-24 |
| CAPSURE SP NOVUS LEAD, CAPSURE SP Z LEAD, CAPSURE Z NOVUS LEAD, VITATRON IMPULSE II LEAD (P850089/S111) | Medtronic Cardiac Rhythm Disease Management | 2014-09-24 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, MAXIMO II CRT-D, PROTECTA XT CRT-D, VIVA QUAD S CRT-D, PROTECTA XT CRT (P010031/S465) | Medtronic Cardiac Rhythm Disease Management | 2014-09-24 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S063) | Medtronic, Inc. | 2014-09-24 |
| XIENCE V AND NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S107) | Abbott Vascular, Inc. | 2014-09-23 |
| GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S060) | W. L. Gore & Associates, Inc. | 2014-09-19 |
| ATTAIN ABILITY LEAD (P080006/S071) | Medtronic, Inc. | 2014-09-18 |
| INCEPTA, ENERGEN, PUNCTUA, DYNAGEN, INOGEN AND ORIGEN ICD'S (P960040/S331) | Boston Scientific | 2014-09-18 |
| INCEPTA, ENERGEN, PUNCTUA, DYNAGEN, INOGEN AND ORIGEN CRT-DS (P010012/S370) | Boston Scientific Corp | 2014-09-18 |
| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S026) | Boston Scientific Corp | 2014-09-17 |
| PROMUS ELEMENT PLUS & PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM STENT SYSTEMS (P110010/S090) | Boston Scientific Corp | 2014-09-17 |
| VOLTA(1CR/2CR/CT/2CT) ICD LEAD, PROTEGO (S/SD/T/TD) ICD LEAD,KAINOX VCS 60 ICD LEADLINOX SMART (S/SD/T/TD/S DX) ICD LEAD (P980023/S060) | Biotronik, Inc. | 2014-09-16 |
| CELERITY 2D/3D/PILOT STEROID-ELUTING LV LEAD, COROX (-S/-L) BP STEROID-ELUTING LV LEAD (P070008/S054) | Biotronik, Inc. | 2014-09-16 |
| DEXTRUS, SELOX ST/JT, SETROX S, AND TILDA T/JT/R STEROID-ELUTING PACING LEADS; SOLOX SLX -BP PACING LEAD (P950037/S138) | Biotronik, Inc. | 2014-09-16 |
| PROMUS ELEMENT PLUS PLATINUM CHROMIUM EVEROLIMUS-ELUTING CORONARY STENT SYSTEM & PROMUS PREMIER EVEROLIMUS-ELUTING PLATI (P110010/S092) | Boston Scientific Corp | 2014-09-12 |
| FRONTIER/ FRONTIER II / ANTHEM FAMILY OF CRT-P'S (P030035/S123) | ABBOTT MEDICAL | 2014-09-12 |
| AFFINITY, INTEGRITY, VICTORY, ZEPHYR, & ACCENT FAMILY OF PACEMAKERS (P880086/S245) | ABBOTT MEDICAL | 2014-09-12 |
| CELSIUS FLTR UNI-DIRECTIONAL CATHETER (P950005/S052) | Biosense Webster, Inc. | 2014-09-12 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D AND VIVA XT CRT-D (P010031/S462) | Medtronic Cardiac Rhythm Disease Management | 2014-09-12 |
| QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-D'S (P030054/S273) | ABBOTT MEDICAL | 2014-09-12 |
| BRAVA CRT-D, BRAVA QUADA CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S463) | Medtronic Cardiac Rhythm Disease Management | 2014-09-12 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S105) | Boston Scientific Corp | 2014-09-12 |
| THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER (P040036/S045) | Biosense Webster, Inc. | 2014-09-12 |
| SENSOLOG/ DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S089) | St. Jude Medical, Inc. | 2014-09-12 |
| MICRONY FAMILY OF PACEMAKERS (P970013/S060) | ABBOTT MEDICAL | 2014-09-12 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S498) | Medtronic Cardiac Rhythm Disease Management | 2014-09-12 |
| CELSIUS FLTR BI-DIRECTIONAL CATHETER (P010068/S041) | Biosense Webster, Inc. | 2014-09-12 |
| THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER (P030031/S060) | Biosense Webster, Inc. | 2014-09-12 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S499) | Medtronic Cardiac Rhythm Disease Management | 2014-09-12 |
| ELLIPSE / FORTIFY ASSURA FAMILY OF ICD'S (P910023/S342) | ABBOTT MEDICAL | 2014-09-12 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (P030011/S027) | Syncardia Systems, LLC | 2014-09-12 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S002) | Edwards Lifesciences, LLC | 2014-09-12 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S003) | Boston Scientific Corp | 2014-09-12 |
| MEDTRONIC 4195 ATTAIN STARFIX MODEL 4195 LV LEAD (P060039/S062) | Medtronic, Inc. | 2014-09-12 |
| HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM (P100047/S047) | Medtronic | 2014-09-12 |
| PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S093) | Boston Scientific Corp | 2014-09-11 |
| NIRXCELL COCR CORONARY STENT ON RX (P110004/S005) | Medinol, Ltd. | 2014-09-11 |
| FLEXTOME CUTTING BALLOON MICROSURGICAL DILATATION DEVICE (P950020/S069) | Boston Scientific Corp | 2014-09-11 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S106) | Boston Scientific Corp | 2014-09-11 |
| ADAPTA, VERSA, SENSIA IPG, RELIA IPG (P980035/S390) | Medtronic, Inc. | 2014-09-10 |
| ORIGEN, INOGEN, DYNAGEN, CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D) (P010012/S369) | Boston Scientific Corp | 2014-09-10 |
| RF ENHANCR II, RF MARINR 7FR, RF MARINR 5FR, RF MARINR UNIPOLAR, RF CONTACTR, RF CONDUCTR (P930029/S044) | Medtronic, Inc. | 2014-09-10 |
| EVERA S D DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S497) | Medtronic Cardiac Rhythm Disease Management | 2014-09-10 |
| BRAVA & QUAD CRT-DS, VIVA QUAD S & XT CRT-DS, VIVA S & XT CRT-DS (P010031/S461) | Medtronic Cardiac Rhythm Disease Management | 2014-09-10 |
| ORIGEN, INOGEN, DYNAGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) (P960040/S330) | Boston Scientific | 2014-09-10 |
| TRIVASCULAR, INC OVATION ABDOMINAL STENT GRAFT SYSTEM, TRIVASCULAR, INC OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM (P120006/S014) | Endologix, LLC | 2014-09-09 |
| MEDTRONIC COREVALVE SYSTEM (P130021/S006) | Medtronic, Inc. | 2014-09-09 |
| CONCERTO, RIGHT VENTRICULAR LEAD INTEGRITY ALERT, CONCERTO II CRT-D, CONSULTA CRT-D, INSYNC UCD, INSYNC II MARQUIS, INSY (P010031/S451) | Medtronic Cardiac Rhythm Disease Management | 2014-09-05 |
| CONSULTA CRT-P, INSYNC, INSYNC III, SYNCRA CRT-P (P010015/S242) | Medtronic, Inc. | 2014-09-05 |
| GEM, JEWEL, MICRO JEWEL, JEWEL PLUS, MICRO JEWEL II, PCD (P900061/S129) | Medtronic Cardiac Rhythm Disease Management | 2014-09-05 |
| JEWEL AF, GEM III AT (P980050/S092) | Medtronic, Inc. | 2014-09-05 |
| ENTRUST, GEM, GEM II, GEM III, INTRINSIC, MARQUIS, MAXIMO, MAXIMO II, ONYX, PROTECTA DF4, PROTECTA, PROTECTA XT DF4, (P980016/S489) | Medtronic Cardiac Rhythm Disease Management | 2014-09-05 |
| PASYS, PASYS ST, SPECTRAX S, SPECTRAX SX, SPECTRAX SX-HT, SPECTRAX SXT, SYMBIOS, SYNERGYST (P820003/S129) | Medtronic Cardiac Rhythm Disease Management | 2014-09-05 |
| OMNILINK ELITE VASCULAR BALLON-EXPANDABLE STENT SYSTEM (P110043/S007) | Abbott Vascular-Cardiac Therapies | 2014-09-05 |
| LIVEWIRE TC AND SAFIRE ABLATION CATHETERS (P960016/S048) | St Jude Medical | 2014-09-05 |
| REVO MRI, ENRHYTHM MRI (P090013/S147) | Medtronic, Inc. | 2014-09-05 |
| ELITE, ELITE II, MINUET, PREVA, PREVA D, PRODIGY, SYNERGYST II, THERA, THERA-I, ANALYZER, VITATRON LEGACY, VITATRON (P890003/S311) | Medtronic, Inc. | 2014-09-05 |
| PCD (P920015/S133) | Medtronic, Inc. | 2014-09-05 |
| DIVA FAMILY (INCLUDES DIAMOND II, RUBY II, TOPAZ II, JADE II, VITA DDDR, VITA DDD AND VITA VVIR) DEMA FAMILY (INCLUDES (P990001/S118) | Medtronic, Inc. | 2014-09-05 |
| VENTAK PRX & VENTAK MINI ICD: LATTITUDE PATIENT MANAGMENT SYSTEM (P910077/S146) | Boston Scientific | 2014-09-05 |
| ACTIVITRAX, ACTIVITRAX II, LEGEND, LEGEND II, MICRO MINIX, MINIX, MINIX ST,PREMIER, PREVAIL, VITATRON LEGACY SR (P850051/S081) | Medtronic, Inc. | 2014-09-05 |
| ADAPTA, ADVISA, AT500, ENPULSE, ENRHYTHM, KAPPA 600, KAPPA 650, KAPPA 700, KAPPA 800, KAPPA 900, RELIA, SENSIA, SIGMA, (P980035/S382) | Medtronic, Inc. | 2014-09-05 |
| KAPPA 400 (P970012/S095) | Medtronic, Inc. | 2014-09-05 |
| LEGEND PLUS (P930022/S016) | Medtronic, Inc. | 2014-09-05 |
| XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S062) | Abbott Vascular | 2014-09-04 |
| ANTHEM, ANTHEM RF, FRONTIER, FRONTIER II (P030035/S124) | ABBOTT MEDICAL | 2014-09-04 |
| ATTAIN STARFIX LEAD (P060039/S059) | Medtronic, Inc. | 2014-09-04 |
| ANGIOJET FAMILY OF THROMBECTOMY SETS (P980037/S043) | Boston Scientific Corp | 2014-09-04 |
| ORIGEN ICD, INOGEN ICD, DYNAGEN ICDS (P960040/S329) | Boston Scientific | 2014-09-04 |
| XIENCE V, XIENCE NANO,XIENCE PRIME, XIENCE PRIME LONG LESION,XIENCE XPEDITION XIENCE XPEDITION SMALL VESSEL AND XPEDITIO (P070015/S117) | Abbott Vascular, Inc. | 2014-09-04 |
| ACCENT, ACCENT RF, ENTITY, IDENTITY, IDENTITY ADX, IDENTITY XL, SUSTAIN XL, VERITY ADX XL, VERITY ADX XL M/S, VERITY ADX (P880086/S246) | ABBOTT MEDICAL | 2014-09-04 |
| EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM (P090003/S029) | Boston Scientific Corporation | 2014-09-04 |
| XIENCE ALPINE RX & OTW EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P110019/S070) | Abbott Vascular | 2014-09-03 |
| CAPSURE SENSE LEAD (P830061/S114) | Medtronic Cardiac Rhythm Disease Management | 2014-09-03 |
| EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (P110023/S010) | Medtronic Vascular, Inc. | 2014-09-03 |
| CAPSUREFIX MRI LEAD (P090013/S153) | Medtronic, Inc. | 2014-09-03 |
| CAPSUREFIX NOVUS LEAD (P930039/S116) | Medtronic, Inc. | 2014-09-03 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S062) | Medtronic, Inc. | 2014-09-03 |
| ENDURANT II STENT GRAFT SYSTEM (P100021/S032) | Medtronic Vascular | 2014-09-03 |
| ANGIOJET ULTRA THOMRBECTOMY SET, ANGIOJET ULTRA SPIROFLEX THOMBRBECTOMY SET, VG THOMRBECTOMY SET, DISTAFLEX THOMBRBECTOM (P980037/S042) | Boston Scientific Corp | 2014-09-02 |
| MEDTRONIC COREVALVE (R) SYSTEM (P130021/S004) | Medtronic, Inc. | 2014-09-02 |
| SUPERA PERIPHERAL STENT SYSTEM (P120020/S005) | Abbott Vascular (Idef Technologies Inc) | 2014-09-02 |