|
Device | Impella 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 | S092 |
Date Received | 12/30/2021 |
Decision Date | 04/05/2022 |
Product Code |
OZD |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for modifications to the labeling to specify the use of the Aortic Placement Signal pressure reading as a diagnostic aortic pressure reading once the catheter is correctly placed with respect to the aortic valve. |