CONSUMER SENSORY PRODUCTS BIO-LOG 8000

FDA 510(k)

FDA Class 2 ·General Hospital

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN STARFIX

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENTRUST/INTRINSIC/MARQUIS/MAXIMO/II/PROTECTA XT/ICD/SECURA/VIRTUOSO II

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TRANSVENE CS/SVC LEAD

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE/SUREFIX/VITATRON CRYSTALLINE ACTFIX/PIROUET S+

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE/CAPSURE Z NOVUS/VITATRON EXCELLENCE S+/SS+/IMPULSE/IMPULSE II

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACCESSORY (UPSIZING SLEEVE) ACE/ACE 5434T/ACE HEADER/LEAD END PIN CAP

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·SELECTSECURE

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE/VITATRON CRYSTALINE/EXCELLENCE +/EXCELLENCE PS+

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Y ADAPTOR/EXTENDER KIT/DF-1 CONNECTOR PORT PIN PLUG/ LEAD ADAPTOR/SPRINT/SPRINT QUATTRO/QUATTRO LEAD/SUBCUTANEOUS LEAD

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE EPICARDIAL PACING LEAD

COLONOSCOPE, 2-CHANNEL LOG (ACMI TX-92)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Resolute Onyx Coronary Stent System

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Resolute Integrity Coronary Stent System

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·Integrity Coronary Stent System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EnVeo PRO Delivery Catheter System (DCS) and Loading System, EnVeo R Delivery Catheter System & Loading System, Evolut P

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Talent Occluder With Occluder Delivery System

Pulmonary Valve Prosthesis Percutaneously Delivered

FDA Pre-Market Approval

Harmony Delivery Catheter System (DCS) and Loading System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VIRTUOSO MODELS D154AWG / D154VWC IMPLANTABLE CARDIOVERTER DEFIBRILLATORS