FDA panel decision means Abiomed will need new PMA for Impella pump
December 7, 2012 by Ingrid Mezo
An FDA advisory panel's decision to maintain Class III status on certain cardiovascular assistance devices means Abiomed and other device makers must re-apply for FDA approval.
An FDA panel decision issued this will require some cardiovascular pump makers to submit their already-approved medical devices for review under the FDA's more stringent premarket review pathway.
News Well, Cardiac Assist Devices, Food & Drug Administration (FDA), Pre-Market Approval (PMA), Regulatory/Compliance
- Show full page
- Login to post comments
-
Permalink
RECENT BLOG POSTS
- Mobilizing on the back end of a disaster
- Rising healthcare costs not directly tied to medical technology, according to study
- CareFusion may be weighing 2 very different deals
- Medical Devices: What does it really mean to be disruptive?
- Smarter strategic moves bode well for Wright Medical
- The IRS, NSA, and Justice Department scandals and what they mean for HIPAA
- A Father's Day remembrance
- What I'd tell the graduating medical school class of 2013
- Silencing immune attacks in type 1 diabetes
- Eucomed guidance clarifies RoHS compliance for medical device companies
Navigation
NEWS
Edwards Lifesciences' Perimount heart valve fares well in 25-year study
A clinical study tracking Edwards Lifesciences' Perimount heart valve over a 25-year span finds that...
St. Jude's Durata defibrillator 'immune' to Riata flaws?
St. Jude Medical's Durata implantable cardiac defibrillator leads should be "relatively immune...
Weight loss: GI Dynamics adds centers in Europe
GI Dynamics says another 5 centers in Europe are offering its EndoBarrier weight-loss device for...
Boston Scientific launches U.S. Parkinson's trial, cites interim EU data
Boston Scientific launches a U.S. clinical trial of its Vercise deep-brain stimulation treatment for...
