Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide Sheath; 4F; 45cm (US-34045-F-ST-H); Catapult Guide Sheath; 4F; 60cm (US-34060-F-ST-H); Catapult Guide Sheath; 4F; 90cm (US-34090-F-ST-H); Catapult Guide Sheath; 4F; 130cm (US-34130-F-ST-H); Catapult Guide Sheath; 5F; 15cm (US-35015-F-ST-H); Catapult Guide Sheath; 5F; 45cm (US-35045-F-ST-H); Catapult Guide Sheath; 5F; 45cm; Hockey Stick (US-35045-F-HS-H); Catapult Guide Sheath; 5F; 45cm; Multipurpose (US-35045-F-MP-H); Ca

FDA 510(k)

FDA Class 2 ·Cardiovascular

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-l ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve

eCordum Cardiac Monitor (eCordum CM)

FDA 510(k)

FDA Class 2 ·Cardiovascular

NovaCross CTO Microcatheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·QUICKSITE XL MODEL 1058T LEFT VENTRICULAR PACING LEAD

MODEL 2872 BIPOLAR LEAD ADAPTOR KIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

PELLETHANE 75D

FDA 510(k)

FDA Class 3 ·Cardiovascular

OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024)

FDA 510(k)

FDA Class 3 ·Cardiovascular

CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER

FDA 510(k)

FDA Class 3 ·Cardiovascular

A1-CS-SB Y-ADAPTER, MODEL 124 871

FDA 510(k)

FDA Class 2 ·Cardiovascular

TECOTHANE 75D POLYURETHANE RESIN FOR PULSE GENERATOR CONNECTOR MODULES

FDA 510(k)

FDA Class 3 ·Cardiovascular

CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACEMAKER

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)

FDA 510(k)

FDA Class 3 ·Cardiovascular

REVEAL INSERTABLE LOOP RECORDER (ILR) SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01

FDA 510(k)

FDA Class 3 ·Cardiovascular

PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV

FDA 510(k)

FDA Class 2 ·Cardiovascular

MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)

FDA 510(k)

FDA Class 3 ·Cardiovascular

MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS

FDA 510(k)

FDA Class 3 ·Cardiovascular