|
Trade Name | CentriMag Right Ventricular Assist System (RVAS) |
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 | S030 |
Date Received | 02/23/2023 |
Decision Date | 01/09/2024 |
Product Code | |
Advisory Committee |
Cardiovascular |
Clinical Trials |
NCT04464785
|
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 centrimag motor locking feature. |