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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 (VAD)
Classification Nameventricular (assisst) bypass
Generic Nameventricular (assisst) bypass
Applicant
THORATEC LABORATORIES CORP.
2023 eighth st.
berkeley, CA 94710
PMA NumberP870072
Supplement NumberS053
Date Received04/22/2013
Decision Date06/21/2013
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 THE CHANGE IN SECONDARY PACKAGING OF THE VAD SEALED ARTERIAL CANNULA AND THE INTERMEDIATE BULK SHIPMENT CONFIGURATION.
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