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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(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
Generic NameVentricular (assist) bypass
ApplicantThoratec Laboratories Corp.
2023 Eighth St.
Berkeley, CA 94710
PMA NumberP870072
Supplement NumberS003
Date Received10/18/1996
Decision Date04/17/1997
Withdrawal Date10/05/2020
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR ADDING AN ALTERNATE CONTRACT STERILIZER FACILITY, AND CHANGING THE MATERIAL AND CONFIGURATION OF THE STORAGE BOX FOR THE PUMPS AND CANNULAE
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