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 II LVAS |
Generic Name | Ventricular (assist) bypass |
Applicant | Abbott Medical 6035 Stoneridge Drive Pleasanton, CA 94588 |
PMA Number | P060040 |
Supplement Number | S065 |
Date Received | 01/04/2017 |
Decision Date | 06/30/2017 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval to revise the Instruction for Use (IFU) for the HeartMate II LVAS to include a summary of results from the PREVENT post-market study, post-approval rates of pump thrombosis, and changes to the clinical management guidelines. |
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