Free Newsletter
Register for our Free Newsletters
Newsletter
Zones
Analysis, Inspection and Laboratory
LeftNav
Assisted/Independent Living
LeftNav
Clinical and Nursing Equipment
LeftNav
Design and Manufacture of Medical Equipment
LeftNav
Diagnostics Equipment, Monitoring and Test
LeftNav
Education, Training and Professional Services
LeftNav
Health Education and Patient Management
LeftNav
Health Estates Management
LeftNav
Healthcare Support and Information Services
LeftNav
Hygiene and Infection Control
LeftNav
IT and Communications in Healthcare
LeftNav
Materials
LeftNav
Medical Device Technology
LeftNav
Research and Development
LeftNav
Safety and Security
LeftNav
View All
Other Carouselweb publications
Carousel Web
Defense File
New Materials
Pro Health Zone
Pro Health Zone
Pro Security Zone
Web Lec
Pro Engineering Zone
 
 
News

Abiomed updates FDA status of its Impella 2.5 circulatory support device

Abiomed : 28 March, 2008  (New Product)
Abiomed has issued an update on the 510(k) clearance process related to its Impella 2.5 circulatory support device.
Abiomed remains confident that the Impella 2.5 device is on the substantially equivalent (SE) path based on informal feedback from the US Food and Drug Administration (FDA). Abiomed is currently in an interactive review with the FDA on bench testing results of the Impella 2.5, the remaining area of concern. Abiomed does not anticipate additional bench testing studies at this time, but remains prepared to answer any questions from the FDA during the ongoing discussions.

Abiomed believes that the FDA will not complete the review of the bench testing results before March 31, 2008, as originally estimated by the company in November 2006. The estimate was a company forecast and not an FDA timeline or deadline. Abiomed now estimates that the review of the bench testing results by the FDA will be completed some time during the quarter ending June 30, 2008.

'While we had hoped this would be completed before the end of our fiscal year, we remain confident that we are on a 510(k) clearance path for the Impella 2.5,' stated Michael R Minogue, chairman, president and chief executive officer of Abiomed.
Bookmark and Share
 
Home I Editor's Blog I News by Zone I News by Date I News by Category I Special Reports I Directory I Events I Advertise I Submit Your News I About Us I Guides
 
   © 2012 ProHealthServiceZone.com
Netgains Logo