| TACHY ADAPTER (ACCESSORY) (P830060/S069) | Boston Scientific | 2011-06-17 |
| ITREL 3 IMPLANTABLE PULSE GENERATOR/SYNERGY/SYNERGY VERSITREL/RESTOREPRIME IMPLANTABLE NEUROSTIMULATOR/PRIMEADVANCED (P840001/S187) | Medtronic Neuromodulation | 2011-06-17 |
| ACUITY LEADS (P050046/S011) | Guidant Corp. | 2011-06-17 |
| INTERSTIM/INTERSTIM II INS (P970004/S114) | Medtronic Neuromodulation | 2011-06-17 |
| ENDOTAK/ ENDOTAK RELIANCE/ENDOTAK ENDURANCE LEADS (P910073/S098) | Boston Scientific | 2011-06-17 |
| ABSORBABLE ADHESION BARRIER (P880047/S015) | ETHICON, Inc. | 2011-06-17 |
| FLEXTEND LEADS (P960006/S031) | Boston Scientific | 2011-06-17 |
| INTERSTIM/INTERSTIM II INS (P080025/S006) | Medtronic Neuromodulation | 2011-06-17 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S120) | Boston Scientific Corp | 2011-06-16 |
| RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS/ITREL 3 IMPLANTABLE NEUROSTIMULATOR/SYNERGY FAMILY OF IMPLANTABLE NEUROST (P840001/S186) | Medtronic Neuromodulation | 2011-06-16 |
| ATTAIN STARFIX (P060039/S023) | Medtronic, Inc. | 2011-06-16 |
| CAPSURE/Z NOVUS/VITATRON EXCELLENCE SS+/IMPULSE II (P850089/S074) | Medtronic Cardiac Rhythm Disease Management | 2011-06-16 |
| SYNCHROMED II IMPLANTABLE INFUSION PUMPS/INTRA-ARTERIAL VASCULAR CATHETERS/VASCULAR CATHETERS/INDURA 1P INTRATHECAL CATH (P860004/S152) | Medtronic, Inc. | 2011-06-16 |
| CAPSURE VDD2 LEAD / BRILLIANT ST LEAD (P890003/S218) | Medtronic, Inc. | 2011-06-16 |
| VISTAKON (ETAFILCON A) BRAND CONTACT LENSES (N18033/S058) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2011-06-16 |
| CAPSURE FIX MRI LEAD (P090013/S010) | Medtronic, Inc. | 2011-06-16 |
| CAPSURE/SUREFIX/VITATRON CRYSTALLINE ACTFIX & PIROUET S+ (P930039/S049) | Medtronic, Inc. | 2011-06-16 |
| XIENCE V & PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S058) | Abbott Vascular, Inc. | 2011-06-16 |
| ATTAIN LEAD (P010015/S111) | Medtronic, Inc. | 2011-06-16 |
| MULTI-LINK VISION & MULTI-LINK MINI-VISION OTW & RX ML-8 (P020047/S029) | Abbott Vascular | 2011-06-16 |
| INTERSTIM FAMILY OF IMPLANTABLE NEUROSTIMULATORS/LEADS/EXTENSION/TEST STIMULATION LEAD/KIT/ACCESSORIES/ACCESSORY KITS (P970004/S113) | Medtronic Neuromodulation | 2011-06-16 |
| SIDE CATHETER ACCESS PORT KITS/BULK/REFILLS KITS/BULK (P990034/S022) | Medtronic, Inc. | 2011-06-16 |
| VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S021) | Vistakon, Division of Johnson & Johnson Vision Car | 2011-06-16 |
| CAPSURE/VITATRON CRYSTALINE & EXCELLENCE PS+ (P830061/S061) | Medtronic Cardiac Rhythm Disease Management | 2011-06-16 |
| INTERSTIM FAMILY OF IMPLANTABLE NEUROSTIMULATORS/LEADS/EXTENSION/TEST STIMULATION LEAD/KIT/ACCESSORIES/ACCESSORY KITS (P080025/S005) | Medtronic Neuromodulation | 2011-06-16 |
| ACTIVA FAMILY OF IMPLANTABLE NEUROSTIMULATORS/SOLETRA IMPLANTABLE NEUROSTIMULATOR/KINETRA IMPLANTABLE NEUROSTIMULATOR (P960009/S116) | Medtronic, Inc. | 2011-06-16 |
| NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S076) | Cochlear Americas | 2011-06-15 |
| VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S022) | Vistakon, Division of Johnson & Johnson Vision Car | 2011-06-15 |
| NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S077) | Cochlear Americas | 2011-06-15 |
| NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S071) | Cochlear Americas | 2011-06-15 |
| ISERT PY-60AD (P080004/S007) | Hoya Surgical Optics, Inc. | 2011-06-15 |
| THE SPANNER TEMPORARY PROSTATIC STENT (P060010/S009) | Srs Medical | 2011-06-14 |
| RELIANCE IS-1 FAMILY OF LEADS (P910073/S089) | Boston Scientific | 2011-06-14 |
| INFORM HER2 DUAL ISH DNA PROBE COCKTAIL (P100027) | Ventana Medical Systems, Inc. | 2011-06-14 |
| SCULPTRA (INJECTABLE POLY-L-LACTIC ACID) & SCULPTRA AESTHETIC (INJECTABLE POLY -L-LACTIC ACID) (P030050/S010) | Q-Med AB | 2011-06-14 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATOR (P030026/S023) | Ortho-Clinical Diagnostics, Inc. | 2011-06-14 |
| TRANSCYTE, HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE (P960007/S020) | Shire Regenerative Medicine | 2011-06-13 |
| PINNACLE COMPLETE ACETABULAR HIP SYSTEM (P090002) | DePuy Orthopaedics, Inc. | 2011-06-13 |
| GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM (P970021/S030) | Gynecare, Inc. | 2011-06-13 |
| AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S036) | Boston Scientific Corp | 2011-06-13 |
| AXSYM AFP (P820060/S027) | Abbott Laboratories | 2011-06-10 |
| VISTAKON (SENOFILCON) BRAND LENSES (P040045/S019) | Vistakon, Division of Johnson & Johnson Vision Car | 2011-06-10 |
| CAPSURE SP Z LEADS/VITATRON IMPULSE/EXCELLENCE S+/SS+/IMPULSE II LEADS (P850089/S077) | Medtronic Cardiac Rhythm Disease Management | 2011-06-10 |
| EPICARDIAL LEADS AND ACCESSORIES (P900061/S103) | Medtronic Cardiac Rhythm Disease Management | 2011-06-10 |
| SYNCRA/CONSULTA CRT-P (P010015/S124) | Medtronic, Inc. | 2011-06-10 |
| VARIOUS FAMILIES OF ELECTROPHYSIOLOGY SYSTEMS (P930029/S030) | Medtronic, Inc. | 2011-06-10 |
| CAPSURE/VITATRON EXCELLENCE + (P830061/S065) | Medtronic Cardiac Rhythm Disease Management | 2011-06-10 |
| VITATRON PIROUET/S+/CRYSTALLINE ACTFIX/CAPSURE LEADS (P930039/S053) | Medtronic, Inc. | 2011-06-10 |
| AXSYM FREE PSA (P980007/S016) | Abbott Laboratories | 2011-06-10 |
| PROTECTA/PROTECTA XT CRT-D (P010031/S256) | Medtronic Cardiac Rhythm Disease Management | 2011-06-10 |
| ADVISA DR IPG (P980035/S226) | Medtronic, Inc. | 2011-06-10 |
| INTERSTIM SACRAL NERVE STIMULATION SYSTEM (P080025/S008) | Medtronic Neuromodulation | 2011-06-10 |
| IMPLANTABLE PULSE GENERATOR AND PROGRAMMER (P820003/S106) | Medtronic Cardiac Rhythm Disease Management | 2011-06-10 |
| VISTAKON (ETAFILCON A) BRAND CONTACT LENSES (N18033/S056) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2011-06-10 |
| AXSYM TOTAL PSA (P910007/S025) | Abbott Laboratories | 2011-06-10 |
| KAPPA 400 IPG (P970012/S085) | Medtronic, Inc. | 2011-06-10 |
| CAPSURE (DRUG ELUTING) LEAD & PROGRAMMER ACCESSORY (P890003/S225) | Medtronic, Inc. | 2011-06-10 |
| ALAIR BRONCHIAL THERMOPLASTY SYSTEM (P080032/S005) | Boston Scientific Corp | 2011-06-10 |
| TRANSVENE SVC LEAD (P920015/S077) | Medtronic, Inc. | 2011-06-10 |
| BAUSCH & LOMB PUREVISION (BALAFILCON A) SOFT CONTACT LENS (P980006/S019) | Bausch & Lomb, Inc. | 2011-06-10 |
| ATTAIN ABILITY PLUS/ATTAIN ABILITY STRAIGHT LEADS (P080006/S028) | Medtronic, Inc. | 2011-06-10 |
| PROTECTA DR/VR/XT DR/VR ICD (P980016/S302) | Medtronic Cardiac Rhythm Disease Management | 2011-06-10 |
| CONSULTA/SYNCRA CRT-PS (P010015/S123) | Medtronic, Inc. | 2011-06-09 |
| ENTRUST/INTRINSIC/MARQUIS/MAXIMO/II/II/II M4/PROTECTA/XT/PROTECT XT M4/PROTECTA M4/SECURA/SECURA M4/VIRTUOSO/II ICDS (P980016/S301) | Medtronic Cardiac Rhythm Disease Management | 2011-06-09 |
| ABBOTT AXSYM AUSAB (P060003/S005) | Abbott Laboratories, Inc. | 2011-06-09 |
| MODEL 3058 INTERSTIM 2 NEUROSTIMULATOR (P970004/S087) | Medtronic Neuromodulation | 2011-06-09 |
| REVO MRI IPG (P090013/S024) | Medtronic, Inc. | 2011-06-09 |
| ADAPTA/ADVISA/ENRHYTHM/RELIA/SENSIA/VERSA IPG (P980035/S225) | Medtronic, Inc. | 2011-06-09 |
| INTEGRITY CORONARY STENT SYSTEMS (P030009/S054) | Medtronic, Ireland | 2011-06-09 |
| PRODIGY IPG (P890003/S224) | Medtronic, Inc. | 2011-06-09 |
| CONCERTO/CONCERTO II/CONSULTA/DF4/INSYNC II/III/MAXIMO/SENTRY/MAXIMO II/II M4/PROTECTA XT/PROTECTA/PROTECTA XT M4/M4 (P010031/S255) | Medtronic Cardiac Rhythm Disease Management | 2011-06-09 |
| ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S048) | Spectranetics Corp. | 2011-06-08 |
| ATTAIN ABILITY (P080006/S027) | Medtronic, Inc. | 2011-06-08 |
| SECURA DR/VR/VIRTUOSO II DR/VR/MAXIMO II DR/VR/ENTRUST/VIRTUOSO/MAXIMO/INTRINSIC/PROTECTA/PROTECTA XT (P980016/S300) | Medtronic Cardiac Rhythm Disease Management | 2011-06-08 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S063) | W. L. Gore & Associates, Inc. | 2011-06-08 |
| ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S037) | Boston Scientific Corp | 2011-06-08 |
| REVO MRI IPG (P090013/S023) | Medtronic, Inc. | 2011-06-08 |
| VISTAKON (ETAFILCON A) BRAND CONTACT LENSES (N18033/S057) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2011-06-08 |
| CONCERTO ICD/CONSULTA/CONCERTO II/MAXIMO II CRT-D/INSYNC II/III MARQUIS/MARQUIS DR/INSYNC MARQUIS/MAXIMO/SENTRY (P010031/S254) | Medtronic Cardiac Rhythm Disease Management | 2011-06-08 |
| INTERSTIM SACRAL NERVE STIMULATION SYSTEM (P970004/S116) | Medtronic Neuromodulation | 2011-06-08 |
| PRODIGY IPG (P890003/S223) | Medtronic, Inc. | 2011-06-08 |
| SLS SPECTRANETICS LASER SHEATHS (P960042/S030) | Spectranetics (Philips) | 2011-06-08 |
| ARCHITECT TOTAL PSA (LN 6C06) (P910007/S023) | Abbott Laboratories | 2011-06-08 |
| AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS (P060022/S011) | Bausch & Lomb, Inc. | 2011-06-08 |
| SYNCRA/CONSULTA CRT-P (P010015/S122) | Medtronic, Inc. | 2011-06-08 |
| VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S020) | Vistakon, Division of Johnson & Johnson Vision Car | 2011-06-08 |
| VIFILCON A SOFT CONTACT LENSES FOR EXTENDED WEAR (P820021/S033) | Alcon Laboratories, Inc. | 2011-06-08 |
| ADAPTA/VERSA/SENSIA/SIGMA/RELIA/ADVISA DR/ENRHYTHM IPGS (P980035/S224) | Medtronic, Inc. | 2011-06-08 |
| SUSTAIN XL FAMILY OF PACEMAKERS (P880086/S204) | ABBOTT MEDICAL | 2011-06-08 |
| DEPUY CERMAX CERAMIC TOTAL HIP SYSTEM (P070026/S001) | DePuy Orthopaedics, Inc. | 2011-06-07 |
| ION (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL & OTW) (P100023/S001) | Boston Scientific Corp | 2011-06-07 |
| ZENITH FLEX AAA ENDOVASCULAR GRAFT (P020018/S037) | Cook, Inc. | 2011-06-07 |
| THERAPY CARDIAC ABLATION CATHETER (P040014/S017) | Irvine Biomedical, Inc. | 2011-06-06 |
| THERAPY DUAL 8/THERAPY 8MM THERMISTOR/SAFIRE TX ABLATION CATHETERS (P040042/S022) | Irvine Biomedical,Inc.(Ibi) | 2011-06-06 |
| DEXCOM SEVEN PLUS SYSTEM (P050012/S037) | Dexcom, Inc. | 2011-06-03 |
| VNS THERAPY SYSTEM PULSE GENERATORS (P970003/S127) | LivaNova USA, Inc. | 2011-06-03 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S069) | Cochlear Americas | 2011-06-03 |
| MEDTRONIC ATTAIN ABILITY MODEL 4196 LEFT VENTRICULAR LEAD (P080006/S026) | Medtronic, Inc. | 2011-06-02 |
| ENDOTAK RELIANCE TACHY LEAD (P910073/S097) | Boston Scientific | 2011-06-02 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S064) | Medtronic, Inc. | 2011-06-02 |