|
Device | Impella 2.5, Impella CP and CP with SmartAssist |
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 | S110 |
Date Received | 03/28/2023 |
Decision Date | 04/27/2023 |
Product Code |
OZD |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT05820451
|
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the revised protocol for the Impella Real-World Surveillance of patients using Sodium Bicarbonate. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval orders for P140003/S088 and P170011/S035. |