Home » MEDTRONIC SUBMITS FIRST PMA FOR ITS HEART STENT
MEDTRONIC SUBMITS FIRST PMA FOR ITS HEART STENT
Medtronic recently submitted its first pre-market approval (PMA) module to the FDA for its Endeavor drug-eluting heart stent. The PMA represents the company's first step to get U.S. approval for the device, Medtronic said.
The Endeavor stent is made of a cobalt alloy and has a unique modular architecture designed to enhance deliverability over bare metal stents. The stent is coated with the proprietary drug compound ABT-578 and phosphorylcholine, a polymer designed to simulate the outside surface of a red blood cell and mimic the structure of the natural cell membrane. Medtronic received European approval for the stent in July.
KEYWORDS FDAnews Device Daily Bulletin
Upcoming Events
-
25Apr
-
07May
-
14May
-
30May