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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceTHORATEC VENTRICULAR (VAD) ASSIST DEVICE SYSTEM
Generic NameVentricular (assist) bypass
ApplicantTHORATEC LABORATORIES CORP.
2023 EIGHTH ST.
BERKELEY, CA 94710
PMA NumberP870072
Supplement NumberS010
Date Received04/11/2000
Decision Date11/15/2000
Withdrawal Date 10/05/2020
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Expedited Review Granted? No
Combination ProductNo
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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