|
Device | Impella Ventricular Support Systems |
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 | S107 |
Date Received | 10/14/2022 |
Decision Date | 03/29/2023 |
Product Code |
OZD |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for various modifications to the Instructions for Use to add the final results of the Post-Approval Study (PAS) protocol. |