|
Device | CentriMag Circulatory Support System |
Generic Name | Ventricular (assist) bypass |
Applicant | Abbott 6035 Stoneridge Drive Pleasanton, CA 94588 |
PMA Number | P170038 |
Supplement Number | S008 |
Date Received | 08/24/2021 |
Decision Date | 10/22/2021 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the transfer of injection molding equipment and processes for the pump components to a new facility location |