|
Trade Name | CentriMag Right Ventricular Assist System (RVAS, HDE) |
Classification Name | right ventricular bypass (assist) device |
Generic Name | right ventricular bypass (assist) device |
Applicant |
Abbott |
6035 stoneridge drive |
pleasanton, CA 94588 |
|
HDE Number | H070004 |
Supplement Number | S031 |
Date Received | 07/03/2023 |
Decision Date | 09/14/2023 |
Product Code | |
Advisory Committee |
Cardiovascular |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a design change to the packaging of blood pump box of the centrimag right ventricular assist system (rvas). |