Medical Device Approvals

The ARCHITECT ® CORE Reagent Kit , Calibrator, and Controls constitute a laboratory test used to detect antibodies (anti HBc) associated with the hepatitis B virus (HBV) core antigen. (Approved: 4/10/2009)

The Medtronic® Attain Ability™ Model 4196 Lead (Model 4196) is a surgically implanted insulated wire that is designed to be used as part of a biventricular pacemaker system. (Approved: 4/7/2009)

The Adiana Permanent Contraception System is a medical device used in a surgical procedure to permanently occlude the fallopian tubes and provide permanent sterilization for women. The device is comprised of a delivery catheter, silicone matrix tubal... (Approved: 3/3/2009)

These reagents are used with the Invader Call ReporterTM software to identify DNA from human papillomavirus (HPV) types 16 and 18 in cervical samples. If test results are positive, the patient is likely to be infected with HPV type 16, 18 or both 16... (Approved: 3/12/2009)

These reagents are used with the Invader Call Reporter TM softwareto identify human papillomavirus (HPV) DNA from 14 high-risk genital HPV types that are commonly associated with cervical cancer. If test results are positive, the patient is likely to... (Approved: 3/12/2009)

The FC2 female condom is a sheath with one open end. There is an outer ring at the open end, and, although not attached to the condom, there is an inner ring inside the sheath that aids in insertion. (Approved: 3/10/2009)

Synvisc-One™ (hylan G-F 20) is an elastoviscous high molecular weight fluid containing hylan polymers (derivatives of hyaluronan or sodium hyaluronate) produced from chicken combs. Synvisc-One is a single 6 mL injection treatment regimen. The total... (Approved: 2/26/2009)

The LifeStent FlexStar and FlexStar XL Vascular Stent Systems are used to re-open stenotic (narrowed) regions of the superficial femoral and proximal popliteal arteries which supply blood to the legs. (Approved: 2/13/2009)

The NAVISTAR® THERMOCOOL® Irrigated Deflectable Diagnostic/Ablation Catheter is used to destroy (ablate) abnormal heart tissue that causes an intermittent abnormal heartbeat in the upper chambers of the heart (paroxysmal atrial fibrillation). (Approved: 2/6/2009)

The AVS, Inc. XACT ® Foldable Hydrophobic Acrylic UV Light-Absorbing Posterior Chamber IOL is plastic lens used to replace the natural lens after it is removed during cataract surgery to restore vision. (Approved: 2/2/2009)