|
Device | IMPELLA VENTRICULAR SUPPORT SYSTEM |
Generic Name | Temporary non-roller type left heart support blood pump |
Applicant | ABIOMED, INC. 22 CHERRY HILL DR. DANVERS, MA 01923 |
PMA Number | P140003 |
Supplement Number | S008 |
Date Received | 06/07/2016 |
Decision Date | 12/01/2016 |
Product Code |
OZD |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval to expand the indication for use to include high risk percutaneous coronary interventions for the Impella CP. |
Post-Approval Study | Show Report Schedule and Study Progress |