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 | TCI HEARTMATE VE LVAS |
Generic Name | Ventricular (assist) bypass |
Applicant | THORATEC CORP. 6035 STONERIDGE DR. PLEASANTON, CA 94588 |
PMA Number | P920014 |
Supplement Number | S014 |
Date Received | 12/05/2000 |
Decision Date | 03/02/2001 |
Withdrawal Date
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10/03/2014 |
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 TO CHANGE THE METHOD OF CONNECTING THE PERCUTANEOUS CONTROLLER CABLE (P/N 28702) TO THE VE SYSTEM CONTROLLER (C/N 1216). |
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