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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.
 
DeviceHEARTMATE IP & VE LVAS
Classification Nameventricular (assisst) bypass
Generic Nameventricular (assisst) bypass
Applicant
THORATEC CORP.
6035 stoneridge dr.
pleasanton, CA 94588
PMA NumberP920014
Supplement NumberS009
Date Received07/16/1999
Decision Date08/10/1999
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to change the material of the retaining suture that TCI includes with each implant kit from Tevdek II 7-776 to #2 NOVAFIL(TM).
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