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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 TLC-II PORTABLE VAD DRIVER
Classification Nameventricular (assisst) bypass
Generic Nameventricular (assisst) bypass
Applicant
THORATEC LABORATORIES CORP.
2023 eighth st.
berkeley, CA 94710
PMA NumberP870072
Supplement NumberS037
Date Received07/30/2007
Decision Date11/14/2007
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 FOR REDUCING THE MAINTENANCE SERVICE INTERVAL FOR THE TLC II PORTABLE VAD DRIVER TO 1500 HOURS FROM THE CURRENT 3000 HOUR INTERVAL.
Post-Approval StudyShow Report Schedule and Study Progress
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