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 (VAD) ASSIST DEVICE SYSTEM |
Generic Name | Ventricular (assist) bypass |
Applicant | THORATEC LABORATORIES CORP. 2023 EIGHTH ST. BERKELEY, CA 94710 |
PMA Number | P870072 |
Supplement Number | S010 |
Date Received | 04/11/2000 |
Decision Date | 11/15/2000 |
Withdrawal Date
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10/05/2020 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A SURGICAL IMPLANT ACCESSORY KIT WITH THE FOLLOWING ACCESSORIES: VENTRICULAR CANNULA VENTING CONNECTOR, VALVE HOUSING CAPS, CANNULA PLUGS, ATRIAL CANNULA TIP CAP, AND Y-CONNECTOR CAP. THE ACCESSORY KIT WILL BE MANUFACTURED AT HORIZON MEDICAL, INC., SANTA ANA, CALIFORNIA, AND STERILIZED BY STERIGENICS, TUSTIN, CALIFORNIA. |
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