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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 IMPLANTATION VENTRICULAR ASSIST DEVICE (IVAD) SYSTEM
Classification Nameventricular (assisst) bypass
Generic Nameventricular (assisst) bypass
Applicant
THORATEC LABORATORIES CORP.
2023 eighth st.
berkeley, CA 94710
PMA NumberP870072
Supplement NumberS039
Date Received12/27/2007
Decision Date01/31/2008
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL TO REVISE THE IVAD INSTRUCTIONS FOR USE TO DELETE THE REFERENCE TO PARACORPOREAL PLACEMENT OF THE IVAD AND INDICATE THAT THE IVAD SHOULD BE CONTRAINDICATED FOR THE PARACORPOREAL PLACEMENT.
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