| FLEXTOME CUTTING BALLOON MICROSURGICAL DILATATION DEVICE (P950020/S068) | Boston Scientific Corp | 2014-08-29 |
| TRANSVENE CS/SVC LEAD (P980050/S094) | Medtronic, Inc. | 2014-08-29 |
| CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD, MODEL 4195 ATTAIN SUREFIX LEAD (P930039/S115) | Medtronic, Inc. | 2014-08-29 |
| AMVISC AND AMVISC PLUS VISCOSURGICAL DEVICE (P810025/S035) | Bausch & Lomb, Inc. | 2014-08-29 |
| CAPSURE SP NOVUS LEAD, CAPSURE Z NOVUS LEAD (P850089/S110) | Medtronic Cardiac Rhythm Disease Management | 2014-08-29 |
| CAPSURE VDD 2 (P890003/S317) | Medtronic, Inc. | 2014-08-29 |
| PRODIGY IPG (P890003/S316) | Medtronic, Inc. | 2014-08-29 |
| ANALYZER ADAPTOR, ANALYZER CABLE (P890003/S314) | Medtronic, Inc. | 2014-08-29 |
| ATTAIN ABILITY LEAD (P080006/S070) | Medtronic, Inc. | 2014-08-29 |
| ATTAIN BIPOLAR OTW LEAD, LED VENTRICULAR PACING LEAD (P010015/S247) | Medtronic, Inc. | 2014-08-29 |
| GLAUKOS ISTENT TRABECULAR MIRCO-BYPASS STENT SYSTEM (P080030/S011) | Glaukos Corporation | 2014-08-29 |
| LCS TOTAL KNEE SYSTEM (P830055/S147) | Depuy, Inc. | 2014-08-29 |
| MODEL 4195 ATTAIN STARFIX LEAD (P060039/S061) | Medtronic, Inc. | 2014-08-29 |
| THE BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM, THE BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATO (P850022/S023) | Ahp Eos Buyer, Inc. | 2014-08-28 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S076) | Boston Scientific Corp | 2014-08-28 |
| SAPIEN THV WITH RETROFLEX FOR INOPERABLE PATIENTS AND WITH RETROFLEX OR ASCENDRA FOR HIGH RISK OPERABLE (P100041/S056) | Edwards Lifesciences, LLC | 2014-08-28 |
| SOLESTA (P100014/S014) | Palette Life Sciences | 2014-08-28 |
| GEL-ONE (P080020/S011) | Seikagaku Corp. | 2014-08-28 |
| GEL-ONE (P080020/S012) | Seikagaku Corp. | 2014-08-28 |
| PRECISION SPECTRA SYSTEM (P030017/S201) | Boston Scientific Corp | 2014-08-28 |
| ENLITE GLUCOSE SENSOR (P120010/S031) | Medtronic, Inc. | 2014-08-28 |
| GEL ONE (P080020/S010) | Seikagaku Corp. | 2014-08-28 |
| SYNTHES PRODISC-C TOTAL DISC REPLACEMENT (P070001/S013) | Centinel Spine, LLC | 2014-08-27 |
| INTERSTIM IMPLANTABLE NEUROSTIMULATOR FOR BOWEL CONTROL (P080025/S078) | Medtronic Neuromodulation | 2014-08-27 |
| PARADYM VR/DR 8750 & VR 9750, PARADYM RF DR 9750 (ZL101), PARADYM RF VR 9750, PARADYM RF DR 9750 (ZL101 & Z102) (P980049/S101) | MicroPort CRM USA, Inc. | 2014-08-27 |
| SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD, TRANSVENE CS/SVC LEAD (P920015/S139) | Medtronic, Inc. | 2014-08-27 |
| CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROCTECTA CRT-D,PROTECTA XT CRT-D (P010031/S460) | Medtronic Cardiac Rhythm Disease Management | 2014-08-27 |
| SYNTHES PRODISC-L TOTAL DISC REPLACEMENT (P050010/S016) | Centinel Spine, LLC | 2014-08-27 |
| ACTIVA SC, ACTIVA SC, KINETRA, SOLETRA (P960009/S200) | Medtronic, Inc. | 2014-08-27 |
| CERVICAL-STIM (P030034/S007) | Orthofix, Inc. | 2014-08-27 |
| COGNIS, INCEPTA, ENERGEN, PUCTUA, DYNAGEN, INOGEN, ORIGEN; CRT-D'S (P960040/S328) | Boston Scientific | 2014-08-27 |
| RESTORE, PRIME ADVANCED, ITREL, AND SYNERGY FAMILIES OF IMPLANTABLE NEUROSTIMULATORS (P840001/S280) | Medtronic Neuromodulation | 2014-08-27 |
| FREEZOR MAX CARDIAC CRYOABLATION CATHETER (P100010/S037) | Medtronic Cryocath, LP | 2014-08-27 |
| INTERSTIM, INTERSTIM II (P970004/S181) | Medtronic Neuromodulation | 2014-08-27 |
| INTERSTIM IMPLANTABLE NEUROSTIMULATOR FOR URINARY CONTROL (P970004/S182) | Medtronic Neuromodulation | 2014-08-27 |
| ARCTIC FRONT ADVANCE CRYOBALLOON CATHETER (P100010/S042) | Medtronic Cryocath, LP | 2014-08-27 |
| INTERSTIM, INTERSTIM II (P080025/S077) | Medtronic Neuromodulation | 2014-08-27 |
| ACTIVA FAMILY FOR DEEP BRAIN STIMULATION -TREMOR CONTROL (P960009/S202) | Medtronic, Inc. | 2014-08-27 |
| CAMERON HEALTH SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM (P110042/S040) | Boston Scientific Corporation | 2014-08-27 |
| FREEZOR CARDIAC CRYOABLATION CATHETER, XTRA SURGICAL CRYOABLATION CATHETER, MAX SURGICAL CARDIAC CRYOABLATION CATHETER (P020045/S055) | Medtronic Cryocath, LP | 2014-08-27 |
| ITREL 4, ITREL 4, ITREL 3, SYNERGY, SYNERGY VERSITREL (P840001/S279) | Medtronic Neuromodulation | 2014-08-27 |
| REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR (P950029/S095) | MicroPort CRM USA, Inc. | 2014-08-27 |
| PARADYM CRT-D 8750, PARADYM RF CRT-D9750 (ZL101), PARADYM CRT-D9750 (ZL102) (P060027/S068) | MicroPort CRM USA, Inc. | 2014-08-27 |
| PHYSIO-STIM AND SPINAL-STIM (P850007/S033) | Orthofix, Inc. | 2014-08-27 |
| REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR (P950029/S094) | MicroPort CRM USA, Inc. | 2014-08-27 |
| TRANSVENE CS/SVC LEAD (P980050/S095) | Medtronic, Inc. | 2014-08-27 |
| TELIGEN, INCEPTA, ENERGEN, PUNCTUA, DYNAGEN, INOGEN, ORIGEN; ICD'S (P010012/S368) | Boston Scientific Corp | 2014-08-27 |
| MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S496) | Medtronic Cardiac Rhythm Disease Management | 2014-08-27 |
| NG3 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, DYNAGEN EL ICD, DYNAGEN MINI ICD, INOGEN EL ICD, INOGEN MINI ICD,ORIGEN EL (P960040/S320) | Boston Scientific | 2014-08-26 |
| SENOCLAIRE (P130020) | GE Healthcare | 2014-08-26 |
| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S028) | Boston Scientific Corp | 2014-08-26 |
| NG3 CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D),DYNAGEN CRT-D,DYNAGEN X4 CRT-D,INOGEN CRT-D,INOGEN X4 CRT-D, (P010012/S359) | Boston Scientific Corp | 2014-08-26 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S152) | Boston Scientific Corp | 2014-08-26 |
| RADIESSE (P050037/S053) | Merz North America, Inc. | 2014-08-25 |
| ARTEGRAFT COLLAGEN VASCULAR GRAFT (N16837/S017) | LeMaitre Vascular, Inc. | 2014-08-25 |
| GEL-ONE (P080020/S009) | Seikagaku Corp. | 2014-08-25 |
| RADIESSE (P050052/S058) | Merz North America, Inc. | 2014-08-25 |
| TITAN INFLATABLE PENILE PROSTHESIS (P000006/S036) | Coloplast Corp. | 2014-08-25 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S040) | Medtronic | 2014-08-25 |
| NUCLEUS 24 HYBRID SYSTEM (P130016/S008) | Cochlear Americas | 2014-08-22 |
| NEUROPACE RNS SYSTEM (P100026/S024) | NeuroPace, Inc. | 2014-08-22 |
| DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S027) | Dexcom, Inc. | 2014-08-22 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, V2.0 (P060030/S043) | Roche Molecular Systems, Inc. | 2014-08-22 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S103) | W. L. Gore & Associates, Inc. | 2014-08-22 |
| ARCTIC FRONT CRYOBALLOON CATHETER, ARCTIC FRONT ADVANCE CRYOBALLOON CATHETER (P100010/S041) | Medtronic Cryocath, LP | 2014-08-22 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S122) | Cochlear Americas | 2014-08-22 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S029) | Boston Scientific Corporation | 2014-08-22 |
| LIVEWIRE TC CARDIAC ABLATION SYSTEM CATHETER (P960016/S047) | St Jude Medical | 2014-08-22 |
| MINIMED 530G INSULIN PUMP (P120010/S005) | Medtronic, Inc. | 2014-08-21 |
| ESTEEM (P090018/S026) | Envoy Medical Corporation | 2014-08-21 |
| PARADIGM REAL-TIME INSULIN PUMP (P980022/S147) | Medtronic Minimed | 2014-08-21 |
| SYNVISC, SYNVISC-ONE (P940015/S033) | Sanofi Genzyme Corp. | 2014-08-21 |
| CVX-300 AND CVX-300-P EXCIMER LASER SYSTEMS (P910001/S073) | Spectranetics Corp. | 2014-08-21 |
| NEUROPACE RNS SYSTEM (P100026/S023) | NeuroPace, Inc. | 2014-08-21 |
| EXOGEN ULTRASOUND BONE HEALING SYSTEM (P900009/S037) | Bioventus, LLC | 2014-08-21 |
| THERAKOS UVAR XTS AND THERAKOS CELLEX PHOTOPHERESIS SYSTEM (P860003/S076) | Therakos Development Limited | 2014-08-21 |
| ATTAIN STARFIX LEAD (P060039/S060) | Medtronic, Inc. | 2014-08-20 |
| OPEN PIVOT HEART VALVE (OPHV) AND OPEN PIVOT AORTIC VALVED GRAFT (OPAVG) (P990046/S038) | Medtronic Ats Medical, Inc. | 2014-08-20 |
| ANCHORING SLEEVE KIT, SELECTSECURE LEAD (P030036/S072) | Medtronic Cardiac Rhythm Disease Management | 2014-08-20 |
| RADIESSE 0.8CC, RADIESSE 1.5CC, RADIESSE 3.0CC (P050052/S056) | Merz North America, Inc. | 2014-08-20 |
| END CAP, EPICARDIAL PATCH LEAD, UPSIZING SLEEVE (P900061/S130) | Medtronic Cardiac Rhythm Disease Management | 2014-08-20 |
| TRANSVENE CS/SVC LEAD (P980050/S093) | Medtronic, Inc. | 2014-08-20 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S061) | Medtronic, Inc. | 2014-08-20 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D, VIVA (P010031/S457) | Medtronic Cardiac Rhythm Disease Management | 2014-08-20 |
| PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEM (P060001/S022) | Medtronic Vascular, Inc. | 2014-08-20 |
| ACRYSOL IQ RESTOR (P040020/S055) | Alcon Research, Ltd. | 2014-08-20 |
| CAPSURE SP NOVUS LEAD, CAPSURE SP Z LEAD,CAPSURE Z NOVUS LEAD, VITATRON IMPULSE II LEAD (P850089/S109) | Medtronic Cardiac Rhythm Disease Management | 2014-08-20 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA I (P980016/S494) | Medtronic Cardiac Rhythm Disease Management | 2014-08-20 |
| Y ADAPTOR/EXTENDER KIT, DF-1 CONNECTOR PORT PIN PLUG, HV SPLITTER/ADAPTOR KIT, IS-1 CONNECTOR PORT PIN PLUG KIT, LEAD (P920015/S136) | Medtronic, Inc. | 2014-08-20 |
| CAPSURE VDD 2, VITATRON BRILLIANT S+ VDD LEAD, VITATRON BRILLIANT S+ VDD LEAD (P890003/S315) | Medtronic, Inc. | 2014-08-20 |
| PIPELINE EMBOLIZATION DEVICE (P100018/S012) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2014-08-20 |
| EVERFLEX SELF EXPANDING PERIPHERAL STENT SYSTEM (P110023/S011) | Medtronic Vascular, Inc. | 2014-08-20 |
| ADAPTA, VERSA, SENSIA IPG (P980035/S386) | Medtronic, Inc. | 2014-08-20 |
| ATTAIN BIPOLAR OTW LEAD, LEFT VENTRICULAR PACING LEAD (P010015/S245) | Medtronic, Inc. | 2014-08-20 |
| CAPSURE SENSE LEAD, CAPSURE SP LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE LEAD, VITATRON EXCELLENCE PS+ LEAD (P830061/S112) | Medtronic Cardiac Rhythm Disease Management | 2014-08-20 |
| ATTAIN ABILITY LEAD (P080006/S069) | Medtronic, Inc. | 2014-08-20 |
| RADIESSE 0.8CC, RADIESSE1.5CC, RADIESSE 3.0 CC (P050037/S051) | Merz North America, Inc. | 2014-08-20 |
| CAPSUREFIX LEAD (P930039/S113) | Medtronic, Inc. | 2014-08-20 |
| CAPSUREFIX MRI LEAD (P090013/S150) | Medtronic, Inc. | 2014-08-20 |
| RADIESSE 0.8CC, RADIESSE 1.5CC, RADIESSE 3.0 CC (P050052/S057) | Merz North America, Inc. | 2014-08-19 |