Medical Device Approvals
Thoratec HeartMate II® Left Ventricular Assist System (LVAS)
The HeartMate II LVAS is a left ventricular assist device (LVAD) system, which is a device that helps the heart's left ventricle (the main pumping chamber of the heart) deliver blood to the rest of the body. (Approved: 1/20/2010)
Medtronic Melody® Transcatheter Pulmonary Valve
The Medtronic Melody® Transcatheter Pulmonary Valve is a manufactured replacement pulmonary heart valve that had already been previously repaired. The pulmonary valve is one of four valves in the human heart that help pump blood throughout the body. (Approved: 1/25/2010)
ProGEL™ Pleural Air Leak Sealant
The ProGEL™ Pleural Air Leak Sealant is a surgical sealant made of human serum albumin and a polyethylene glycol (PEG) crosslinker that forms a clear flexible gel on mixing. Surgeons use the device to seal air leaks on lung tissue after standard closure.. (Approved: 1/14/2009)
CONSERVE® Plus Total Resurfacing Hip System
The CONSERVE® Plus Total Resurfacing Hip System is a metal on metal resurfacing artificial hip replacement system, surgically implanted to replace a hip joint. The CONSERVE® Plus Total Resurfacing Hip System is called a resurfacing prosthesis because... (Approved: 11/3/2009)
VIDAS fPSA rt Assay
The VIDAS fPSA rt Assay is a lab tests, used along with digital rectal examination, to help diagnose prostate cancer in men age 50 years and older. (Approved: 10/8/2009)
DuraSeal Spine Sealant System
The DuraSeal Spine Sealant System is used in spinal surgery and applied over sutures (stitches) to prevent cerebrospinal fluid (CSF) from leaking out of the incision site. (Approved: 9/4/2009)
Sculptra Aesthetic
Sculptra Aesthetic is an implant of poly-L-lactic acid (PLLA) microparticles. It is injected into the facial tissue to correct shallow to deep smile lines (nasolabial fold) contour deficiencies and other facial wrinkles. (Approved: 7/28/2009)
- Login or register to post comments
- 136 reads
- Feed: Medical Device Approvals
- Original article
TAXUS® Liberte™ Long (2.75?4.00 mm x 38 mm) Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the Wire Delivery Systems)
The TAXUS® Liberte™ Long (2.75?4.00 mm x 38 mm) Paclitaxel-Eluting Coronary Stent is an expandable, mesh-like stainless steel tube with a drug (paclitaxel) contained within a thin polymer coating on its surface. (Approved: 7/13/2009)
- Login or register to post comments
- 182 reads
- Feed: Medical Device Approvals
- Original article
TAXUS® Liberté® Atom™ (2.25 mm) Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the Wire Delivery Systems)
The TAXUS® Liberté® Atom™ (2.25 mm) Paclitaxel-Eluting Coronary Stent is an expandable, mesh-like stainless steel tube with a drug (paclitaxel) contained within a thin polymer coating on its surface. (Approved: 5/21/2009)
- Login or register to post comments
- 181 reads
- Feed: Medical Device Approvals
- Original article
BRYAN® Cervical Disc
The BRYAN® Cervical Disc is a titanium and polyurethane device that fits between adjacent neck bones (vertebral bodies) to replace a diseased or bulging cervical disc that is causing neck or arm pain. (Approved: 5/12/2009)
- Login or register to post comments
- 178 reads
- Feed: Medical Device Approvals
- Original article
