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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.
Generic Nameventricular (assist) bypass
2023 eighth st.
berkeley, CA 94710
PMA NumberP870072
Supplement NumberS006
Date Received12/22/1997
Decision Date01/21/1998
Withdrawal Date 10/05/2020
Product Code DSQ 
Docket Number N
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for 1) changing the thread sealant/thread locking material for the stinless steel pneumatic driveline fitting to the polysulfone VAD case cap from room temperature vulcanizing (RTV) silicone to Master Bond Polymer System EP21LV, and 2) replacing the current two-piece welded hand pump bulb witha single-piece molded bulb.