Abiomed readies PMA application for Impella heart pump

05/7/2013 | MassDevice.com (Boston)

Abiomed plans to file a premarket approval application with the FDA for its Impella heart pump at the close of fiscal year 2014. With the trove of data showing real-world use of the device, which already has 510(k) clearance, CEO Michael Minogue believes Abiomed could get the PMA without having to conduct another trial. "We'd like to be one of the first success stories in the industry that's converted from a 510(k) through the 515 process to PMA," he said.

View Full Article in:

MassDevice.com (Boston)

Published in Briefs:

SmartBrief Job Listings for Health Care

Job Title Company Location
MGR POST MARKET STUDIES - 14000001LK
Abbott
Santa Ana, CA
Regulatory Analyst
Delta Dental
Alpharetta, GA
Associate Director, Regulatory Affairs - Promotional Review
Novo Nordisk
Princeton, NJ
Eastern Zone Sales Director
Regenesis Biomedical
Multiple Locations, SL_Multiple Locations
Senior Financial Analyst - Growing Manager Care Health Org
Fallon Community Health Plan
Worcester, MA