Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | HeartMate 3™ Left Ventricular Assist System |
Generic Name | Ventricular (assist) bypass |
Applicant | Abbott Medical 6035 Stoneridge Drive Pleasanton, CA 94588 |
PMA Number | P160054 |
Supplement Number | S006 |
Date Received | 04/12/2018 |
Decision Date | 05/31/2018 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for updating the packaging materials for the existing Modular Cable Cap and Coring Knife standalone packaging configurations, and introducing a standalone packaging configuration for the Apical Cuff, Skin Coring Punch, Thread Protectors, and Tunneling Adapter. |
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