| SYNERGYST II PULSE GENERATOR (P890003/S071) | Medtronic, Inc. | 2003-09-17 |
| MEDTRONIC MODEL 2490D/E CARELINK MONITORS AND MODEL 2491 DDMA SOFTWARE FOR INSYNC ICD, MODEL 7272 AND INSYNC MARQUIS, M (P010031/S007) | Medtronic Cardiac Rhythm Disease Management | 2003-09-17 |
| VITATRON DA+ C SERIES PULSE GENERATORS (P990001/S014) | Medtronic, Inc. | 2003-09-16 |
| ATS MEDICAL HEART VALVE (P990046/S008) | Medtronic Ats Medical, Inc. | 2003-09-16 |
| WALLSTENT VENOUS ENDOPROSTHESIS (P980033/S007) | Boston Scientific Corporation | 2003-09-11 |
| WALLSTENT LLIAC ENDOPROSTHESIS (P940019/S015) | Boston Scientific Scimed, Inc. | 2003-09-11 |
| WALLSTENT TIPS ENDOPROSTHESIS (P930031/S017) | Boston Scientific Corp | 2003-09-11 |
| GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM (P000052/S020) | Guidant Corp. | 2003-09-03 |
| NC MONORAIL PTC CATHETER, QUANTUM MONORAIL PTCA CATHETER, MAXXUM PTCA CATHETER, VIVA PTCA CATHETER AND ADANTE PTCA CATHR (P860019/S198) | Scimed Life Systems, Inc. | 2003-09-03 |
| EXPRESS/EXPRESS2 CORONARY STENT SYSTEM (P020009/S010) | Boston Scientific Scimed, Inc. | 2003-09-03 |
| MAVERICK MONORAIL/QUANTUM MAVERICK MONORAIL PTCA CATHETERS (P860019/S197) | Scimed Life Systems, Inc. | 2003-09-03 |
| CHILLI II COOLED ABLATION CATHETERS (P980003/S007) | Boston Scientific Corp | 2003-09-02 |
| LIFE VEST, MODEL WCD 3000 (P010030/S004) | Zoll Manufacturing Corporation | 2003-09-02 |
| PROSTAR XL 8 AND 10 FRENCH, CLOSER, CLOSER S, PERCLOSE AT, AND PERCLOSE AT MONOFILAMENT 6 FRENCH SUTURE MEDIATED CLOSER (P960043/S047) | Abbott Vascular, Inc. | 2003-09-02 |
| ANEURX STENT GRAFT WITH XPEDIRNT DELIVERY SYSTEM (P990020/S016) | Medtronic Vascular | 2003-08-29 |
| FX MINIRAIL RX PTCA CATHETER (P020037/S001) | Abbott Vascular, Inc. | 2003-08-28 |
| EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEM (P020025) | Boston Scientific | 2003-08-25 |
| MODEL 5076 CAPSURE FIX NOVUS ELECTRODE (P930039/S016) | Medtronic, Inc. | 2003-08-25 |
| CARDIOVERSION SWITCHBOX II SYSTEM (P020052/S001) | St Jude Medical | 2003-08-22 |
| CARPENTIER-EDWARDS BIOPROSTHESES, MODELS 2625 (AORTIC) & 6625 (MITRAL), AND CARPENTIER-EDWARDS BIOPROSTHETIC VALVED COND (P870056/S015) | Edwards Lifesciences, LLC | 2003-08-22 |
| AMPLATZER SEPTAL OCCLUDER AND PFO OCCLUDER AMPLATZER 45 DEGREE DELIVERY AND EXANGE SYSTEMS (P000039/S006) | ABBOTT MEDICAL | 2003-08-21 |
| ADX PULSE GENERATOR FIRMWARE ANOMALY CORRECTION (P880086/S095) | ABBOTT MEDICAL | 2003-08-15 |
| ADX PULSE GENERATOR (P910023/S068) | ABBOTT MEDICAL | 2003-08-15 |
| ADX PULSE GENERATOR (P830045/S087) | St. Jude Medical, Inc. | 2003-08-15 |
| QUICKSEAL CONTROL ARTERIAL CLOSURE SYSTEM (P010049/S008) | Sub-Q, Inc. | 2003-08-13 |
| S.M.A.R.T. AND S.M.A.R.T. CONTROL NITINOL STENT SYSTEM (P020036) | Cordis US Corporation | 2003-08-12 |
| ANEURX STENT GRAFT WITH XPEDIENT DELIVERY SYSTEM (P990020/S014) | Medtronic Vascular | 2003-08-08 |
| SPECTRANECTICS VITESSE COS RX CATHETERS, VITESSE E CATHETERS AND EXTREME OTW CATHETERS (P910001/S024) | Spectranetics Corp. | 2003-08-08 |
| ANCURE SYSTEM (P990017/S038) | Boston Scientific Corp | 2003-08-08 |
| MEDTRONIC KAPPA 900/800 PACEMAKER SERIES (P980035/S019) | Medtronic, Inc. | 2003-08-07 |
| CHILLI COOLED ABLATION SYSTEM (P980003/S008) | Boston Scientific Corp | 2003-08-07 |
| PHILOS DR ACC PACING SYSTEM AND PROGRAMMER SOFTWARE VERSION B-KAC.V.U/1 (P950037/S030) | Biotronik, Inc. | 2003-08-04 |
| ATS OPEN PIVOT BILEAFLET HEART VALVE (P990046/S007) | Medtronic Ats Medical, Inc. | 2003-08-01 |
| JOMED JOCATH GLADIATOR PTCA CATHETER (OTW) (P910031/S021) | Abbott Vascular Devices | 2003-08-01 |
| CARBOMEDICS CARBO-SEAL VALSALVA ASCENDING AORTIC PROTHESIS (P900060/S025) | Corcym S.r.l. | 2003-08-01 |
| MARQUIS VR ICD (P980016/S035) | Medtronic Cardiac Rhythm Disease Management | 2003-07-30 |
| PROCOL VASCULAR BIOPROSTHESIS (P020049) | LeMaitre Vascular, Inc. | 2003-07-29 |
| KENTROX RV 65, KENTROX RV 75, KAINOX SL 65/13, KAINOX SL 65/18 (P980023/S013) | Biotronik, Inc. | 2003-07-29 |
| EXPRESS/EXPRESS2 CORONARY STENT SYSTEM (P020009/S009) | Boston Scientific Scimed, Inc. | 2003-07-25 |
| CARBOMEDICS PROSTHETIC HEART VALVE {CPHV} (P900060/S026) | Corcym S.r.l. | 2003-07-25 |
| PTCA CATHETERS (P860019/S196) | Scimed Life Systems, Inc. | 2003-07-25 |
| NIR PREMOUNTED STENT DELIVERY SYSTEMS (P980001/S043) | Boston Scientific Corp | 2003-07-25 |
| GALILEO AND GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEMS (P000052/S019) | Guidant Corp. | 2003-07-24 |
| ACS MULTI-LINK DUET CORONARY STENT SYSTEM (P970020/S043) | Abbott Vascular, Inc. | 2003-07-22 |
| SPRINT QUATTRO STEROID-ELUTING LEAD MODEL 6944 (P920015/S028) | Medtronic, Inc. | 2003-07-21 |
| INSYNC II MARQUIS MODEL 7289 WITH MODEL 9989 APPLICATION SOFTWARE (P010031/S005) | Medtronic Cardiac Rhythm Disease Management | 2003-07-21 |
| NOVOSTE BETA-CATH 3.5F SYSTEM (P000018/S029) | Best Vascular, Inc. | 2003-07-18 |
| MULTI-LINK RX ZETA CORONARY STENT SYSTEM (P970020/S044) | Abbott Vascular, Inc. | 2003-07-16 |
| MULTI-LINK VISION/MINI/8 CORONARY STENT SYSTEMS (P020047) | Abbott Vascular | 2003-07-16 |
| CORDIS PALMAZ BALLOON EXPANDABLE STENTS (P890017/S011) | Cordis US Corporation | 2003-07-15 |
| DUETT PRO MODEL 1010 AND DIAGNOSTIC DUETT PRO MODEL 2210 (P990037/S020) | Vascular Solutions, Inc. | 2003-07-11 |
| CONTAK CD 2 CRT-D SYSTEMS (P010012/S011) | Boston Scientific Corp | 2003-07-10 |
| VITALITY DS ICD SYSTEMS (P960040/S031) | Boston Scientific | 2003-07-10 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S077) | Boston Scientific Corp | 2003-07-08 |
| CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIK LOAD (P000049/S009) | Nmt Medical, Inc. | 2003-07-03 |
| THINLINE II STEROX /FINELINE II STEROX ENDOCARDIAL PACING LEADS (P960004/S022) | Boston Scientific | 2003-07-02 |
| BX VELOCITY STENT ON RAPTORRAIL STENT DELIVERY SYSTEM AND BX VELOCITY STENT WITH HEPACOAT ON RAPTORRAIL STENT DELIVERY (P900043/S044) | Cordis Corp. | 2003-07-02 |
| MODEL 2848 CONTAK CD PROGRAMMER SOFTWARE APPLICATION (VERSION 3.2) (P010012/S012) | Boston Scientific Corp | 2003-07-02 |
| ALTO2 DR MODEL 624 /ALTO2 VR MODEL 625 ICDS (P980049/S009) | MicroPort CRM USA, Inc. | 2003-07-02 |
| ST.JUDE MEDICAL RIATA DEFIBRILLATION LEADS (P950022/S017) | ABBOTT MEDICAL | 2003-07-01 |
| GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM (P000052/S016) | Guidant Corp. | 2003-06-27 |
| BETA-CATH 3.5F SYSTEM - 60 MM (P000018/S028) | Best Vascular, Inc. | 2003-06-25 |
| NOVOSTE BETA-CATH SYSTEM (P000018/S034) | Best Vascular, Inc. | 2003-06-25 |
| VENTAK PRIZM AVT (P960040/S033) | Boston Scientific | 2003-06-25 |
| ENDOTAK RELIANCE STEROID ELUTING ENDOCARDIAL DEFIBRILLATION LEAD (P910073/S042) | Boston Scientific | 2003-06-24 |
| EPT-1000 CARDIAC ABLATION SYSTEM (P920047/S019) | Boston Scientific Corp | 2003-06-19 |
| THE ANEURX STENT SYSTEM (P990020/S012) | Medtronic Vascular | 2003-06-19 |
| EASYTRAK LEAD MODELS IS-1 4535/4536/4537/4538 CORONARY VENOUS STEROID-ELUTING SINGLE-ELECTRODE PACE/SENSE LEAD (P010012/S010) | Boston Scientific Corp | 2003-06-13 |
| DIAGNOSTIC DUETT AND DUETT PRO SEALING DEVICES AND D-STAT FLOWABLE HEMOSTAT (P990037/S019) | Vascular Solutions, Inc. | 2003-06-13 |
| TENDRIL SDX PERMANENT PACEMAKER LEADS, MODELS 1688T/TC (P960013/S013) | ABBOTT MEDICAL | 2003-06-13 |
| CONTAK RENEWAL 3 CRT-D MODELS H170/H175, CONTAK RENEWAL 3 HE CRT-D MODELS H177/H179, AND MODEL 2845 VERSION 2.2 SOFTWARE (P010012/S008) | Boston Scientific Corp | 2003-06-13 |
| NOVOSTE BETA-CATH SYSTEM (P000018/S033) | Best Vascular, Inc. | 2003-06-11 |
| FX MINIRAIL RX PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER (P020037) | Abbott Vascular, Inc. | 2003-06-11 |
| FINISHING WIRE UNIVERSAL (P010012/S013) | Boston Scientific Corp | 2003-06-09 |
| MEDTRONIC SIGMA PACING SYSTEM AND MEDTRONIC 350 SERIES PACING SYSTEM (P980035/S029) | Medtronic, Inc. | 2003-06-06 |
| CUTTING BALLOON ULTRA 2 (P950020/S008) | Boston Scientific Corp | 2003-06-04 |
| FLEXTEND BIPOLAR, STEROID ELUTING, EXTENDABLE/ RETRACTABLE PACING LEAD (P960006/S008) | Boston Scientific | 2003-05-30 |
| TACHOS ATX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM AND PROGRAMMER SOFTWARE (P000009/S007) | Biotronik, Inc. | 2003-05-29 |
| DUETT PRO SEALING DEVICE, DIAGNOSTIC DUETT PRO SEALING DEVICE AND D-STAT FLOWABLE HEMOSTAT (P990037/S018) | Vascular Solutions, Inc. | 2003-05-27 |
| THE ANEURX STENT GRAFT WITH XPEDIENT DELIVERY SYSTEM (P990020/S013) | Medtronic Vascular | 2003-05-23 |
| ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEM (P020018) | Cook, Inc. | 2003-05-23 |
| MODEL VSA02/VSC02 V9.0 PROGRAMMING SOFTWARE FOR THE DIVA, DEMA, AND SELECTION AFM MODEL 902 PULSE GENERATORS (P990001/S012) | Medtronic, Inc. | 2003-05-20 |
| DUETT PRO SEALING DEVICE (MODEL 1010) AND DIAGNOSTIC DUETT PRO SEALING DEVICE (MODEL 2210) (P990037/S015) | Vascular Solutions, Inc. | 2003-05-20 |
| PERCLOSE AT 6 FRENCH SUTURE MEDIATED CLOSER (SMC) SYSTEM, AND PERCLOSE AT MONOFILAMENT 6 FRENCH SUTURE MEDIATED CLOSER M (P960043/S045) | Abbott Vascular, Inc. | 2003-05-16 |
| MEDTRONIC AVE BRIDGE EXTRA SUPPORT OVER-THE-WIRE RENAL STENT SYSTEM (P020007/S001) | Medtronic Vascular | 2003-05-15 |
| THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM (P870072/S021) | Thoratec Laboratories Corp. | 2003-05-14 |
| AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM (P020024) | ABBOTT MEDICAL | 2003-05-14 |
| CARDIAC AIRBAG / CARDIAC AIRBAG-T IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P980023/S014) | Biotronik, Inc. | 2003-05-14 |
| AMPLATZER SEPTAL OCCLUDER, AMPLATZER 45 DEGREE DELIVERY AND EXCHANGE SYSTEMS (P000039/S005) | ABBOTT MEDICAL | 2003-05-13 |
| IDENTITY ADX XL DC,SR/ADX VDR/ADX XL DR,DR,SR/VERITY ADX XL VDR/ADX XL DR,DR,DC/ADX XLSR,SR,SC (P910023/S067) | ABBOTT MEDICAL | 2003-05-09 |
| MDX SILICONE TUBING (P930039/S014) | Medtronic, Inc. | 2003-05-09 |
| EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S003) | Edwards Lifesciences, LLC | 2003-05-09 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS (P870077/S013) | Edwards Lifesciences, LLC | 2003-05-09 |
| IDENTITY ADX XL DC,SR/ADX VDR/ADX XL DR,DR,SR/VERITY ADX XL VDR/ADX XL DR,DR,DC/ADX XLSR,SR,SC (P830045/S086) | St. Jude Medical, Inc. | 2003-05-09 |
| CARPENTIER-EDWARDS S.A.V. PORCINE BIOPROSTHESIS (P010041/S002) | Edwards Lifesciences, LLC | 2003-05-09 |
| MEDTRONIC MODELS CAPSURE SP 4092, CAPSURE SP 4592, CAPSURE SP 4023, CAPSURE SP 4523 AND CAPSURE SENSE 4073; VITATRON... (P830061/S035) | Medtronic Cardiac Rhythm Disease Management | 2003-05-09 |
| IDENTITY ADX XL DC,& SR/ADX VDR/ADX XL DR,DR,SR/VERITY ADX XL VDR/ADX XL DR,DR,DC/ADX XLSR,SR,SC (P880086/S094) | ABBOTT MEDICAL | 2003-05-09 |
| MEDTRONIC MODEL CAPSUREFIX 6940 (P980016/S032) | Medtronic Cardiac Rhythm Disease Management | 2003-05-09 |
| MEDTRONIC MODELS CAPSURE SP 5023M, CAPSURE SP 5524M AND CAPSURE Z 5033 (P850089/S051) | Medtronic Cardiac Rhythm Disease Management | 2003-05-09 |
| MEDTRONIC MODEL 4193 ATTAIN OTW LEAD (P010015/S010) | Medtronic, Inc. | 2003-05-09 |