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 | ABIOMED BVS 5000 BI-VENTRICULAR SUPPPORT SYSTEM |
Generic Name | Ventricular (assist) bypass |
Applicant | ABIOMED CARDIOVASCULAR, INC. 22 CHERRY HILL DRIVE DANVERS, MA 01923 |
PMA Number | P900023 |
Supplement Number | S030 |
Date Received | 10/07/1999 |
Decision Date | 03/13/2000 |
Withdrawal Date
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02/01/2018 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for using model EWS300P-24 AC/DC Converter manufactured by Lambda, Melville, NY as an alternate AC/DC Converter in the BVS 5000 and BVS 5000i consoles. |
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