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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 NumberS004
Date Received05/28/1997
Decision Date07/10/1997
Withdrawal Date 10/05/2020
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for changing the test methodology for measuring molecualr weight of BPS-215 from gel permeation chromatography to intrinsic viscosity during the manufacturing process.
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