|
Device | CentriMag™ Circulatory Support System |
Generic Name | Ventricular (assist) bypass |
Applicant | Abbott 6035 Stoneridge Drive Pleasanton, CA 94588 |
PMA Number | P170038 |
Supplement Number | S010 |
Date Received | 04/13/2022 |
Decision Date | 05/11/2022 |
Product Code |
DSQ |
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 Add an alternate sub-tier supplier for the PTFE felt material used to manufacture the Apical Sewing Ring for the CentriMag Cannula Drainage Kit. |