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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 VENTRICULAR ASSIST DEVICE SYSTEM
Classification Nameventricular (assisst) bypass
Generic Nameventricular (assisst) bypass
Applicant
THORATEC LABORATORIES CORP.
2023 eighth st.
berkeley, CA 94710
PMA NumberP870072
Supplement NumberS034
Date Received07/12/2006
Decision Date06/28/2007
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A MATERIAL CHANGE IN THE TUBING THAT CONNECTS THE BODY OF THE PARACORPOREAL THORATEC VENTRICULAR ASSIST DEVICE WITH THE METAL Y-CONNECTOR THAT SPLITS THE LINE INTO SEPARATE ELECTRICAL AND PNEUMATIC CONNECTIONS.
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