PremierPro

FDA UDI

SVS LLC·00818566016997·Central Line Kit - Tegaderm 1655, Biopatch CHG ...

PremierPro

FDA UDI

SVS LLC·00818566017000·Central Line Kit - Tegaderm 1688, Biopatch CHG ...

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE Xpedition RX/OTW, Apline RX/OTW and Sierra RX Everolimus ELuting Coronary Stent System

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·STRATOS LV/LV-T CRT-P; COROX OTW (-S) BP & PTW-L BP LEADS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Attain Bipolar OTW/Attain OTW LV Lead; Consulta/Percepta Bipolar/Percepta Quadripolar/Serena Bipolar/Serena Quadripolar/

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK FAMILY PTCA BALLOON CATHETERS, MAVERICK OTW, MAVERICK2 MONORAIL (MR), QUANTUM MAVERICK OTW AND QUANTUM MAVERICK

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMAX ICDS/COROX OTW UP STEROID

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS OTW PHOTON CORONARY DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·NC STORMER OTW BALLOON DILATATION CATHETER

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

FDA Pre-Market Approval

FDA Class 3 ·OVATIO CRT & SITUS OTW LV

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

FDA Pre-Market Approval

FDA Class 3 ·OVATIO CRT & SITUS OTW LV

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS OTW PHOTON CORONARY DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·JOMED JOCATH GLADIATOR PTCA CATHETER (OTW)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 4193 ATTAIN OTW LEAD

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·FLEXTOME CUTTING BALLOON OTW PTCA CATHETER

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ZETA RX/ULTRA RX/ULTRA OTW

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS OTW SOLARIS CORONARY DILATATION CATHETER

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·COROX OTW/STRATOS LV/LV-T

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·COROX OTW UP STEROID-ELUTING LEAD

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN BIPOLAR OTW LEAD, ATTAIN OTW LV LEAD, CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P