Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·HYBRID CAPTURE 2 HIGH-RISK HPV DNA TEST AND HYBRID CAPTURE HPV DNA TEST

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·IOPN PACLITAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM

Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees

FDA Pre-Market Approval

FDA Class 3 ·OPRA Implant System

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·BRYAN CERVICAL DISC PROSTHESIS

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·PARAGON Z CRT (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSES FOR CONTACT LENS CORNEAL REFRACTIVE THERAPY

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)

Antigen(Complexed),Prostate Specific,(Cpsa)

FDA Pre-Market Approval

FDA Class 3 ·BAYER ADVIA IMS COMPLEXED PSA ASSAY

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·SCULPTRA AESTHETIC

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·PERCLOSE A-T MONOFILAMENT 6 FR. SUTURE MEDIATED CLOSURE (SMC) SYSTEM

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT ARCHITECT TOTAL PSA ASSAY

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·MODEL 7421 ITREL 7424 ITREL II, 7425 ITREL III AND MODEL 7427 SYNERGY SPINAL CORD STIMULATION (SCS) SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC VENTRICULAR ASIST DEVICE

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·PRODISC TM-C TOTAL DISC REPLACEMENT

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·LADARVISION 4000 EXCIMER LASER SYSTEM AND THE LADAR 6000 EXCIMER LASER SYSTEM

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·BAYER ADVIA IMS PSA ASSAY

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·TALENT ABDOMINAL STENT GRAFT SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·EXCLUDER BIFURCATED ENDOPROSTHESIS

Automated Breast Ultrasound

FDA Pre-Market Approval

FDA Class 3 ·INVENIA ABUS-AUTOMATED BREAST ULTRASOUND SYSTEM