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Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·FLEXTOME CUTTING BALLOON MONORAIL & OVER-THE-WIRE

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Evera, Maximo, Protecta, Secura, Visia MRI VR/XT/DR/AF ICD

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, V2.0

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·NIRFLEX PREMOUNTED CORONARY STENT SYSTEM

Pulmonary Valve Prosthesis Percutaneously Delivered

FDA Pre-Market Approval
Edwards SAPIEN 3™ Transcatheter Heart Valve

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·Freezor Cardiac Cryoablation Catheter, Freezor Xtra Cardiac Cryoablation Catheter, Freezor MAX Cardiac Cryoablation Cath

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Restylane, Perlane, Restylane Lyft (formerly Perlane-L), Restylane Silk

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval
FDA Class 3 ·InterStim® Therapy System

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·LIAISON MUREX Anti-HBc and LIAISON MUREX Control Anti-HBc

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·CHILLI II COOLED ABLATION CATHETER AND CABLE

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·COBAS HBV TEST

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Restylane Refyne, Restylane Defyne, Restylane Kysse Injectable Gels

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·VISCOAT/DISCOVISC/DUOVISC

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·Frequency Xcel Toric (methafilcon A) Soft (Hydrophilic) Extended Wear Contact Lenses. / Frequency Xcel Toric XR (methaf

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval
FDA Class 3 ·Wolverine Coronary Cutting Balloon

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

FDA Pre-Market Approval
FDA Class 3 ·INVIVE, INTUA CARDIAC RESYNCHRONIZATION THERAPY-PACEMAKERS (CRT-PS)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·BIOFINITY (COMFILCON A)

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN HCV TEST

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

FDA Pre-Market Approval
FDA Class 3 ·Acuity X4 Liners

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR