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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.
 
DeviceST JUDE MEDICAL TORONTO SPV VALVE, MODEL SPA-101
Generic Nameheart-valve, non-allograft tissue
ApplicantSt. Jude Medical, Inc.
177 E. County Rd. B E.
St Paul, MN 55117
PMA NumberP970030
Supplement NumberS006
Date Received03/03/2006
Decision Date03/31/2006
Withdrawal Date05/14/2012
Product Code LWR 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGES TO THE INSTRUCTION FOR USE TO ADD AND STRENGTHEN CAUTIONS IN THE USE OF THE DEVICE.
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