|
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 | S034 |
Date Received | 04/16/2024 |
Decision Date | 05/01/2024 |
Product Code | |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement A change in the bacterial endotoxin testing method. |