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 | THORATEC VENTRICULAR ASSIST DEVICE(VAD) SYSTEM |
Generic Name | Ventricular (assist) bypass |
Applicant | THORATEC LABORATORIES CORP. 2023 EIGHTH ST. BERKELEY, CA 94710 |
PMA Number | P870072 |
Supplement Number | S009 |
Date Received | 11/17/1998 |
Decision Date | 03/19/1999 |
Withdrawal Date
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10/05/2020 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement Approval to move manufacturing facility located at Thoratec Lab, 2023 Eighth St., Berkeley, CA, to Thoratec Lab, 6035 Stoneridge Dr., Pleasanton, CA. |
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