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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 TORONTO SPV VALVE
Generic Nameheart-valve, non-allograft tissue
ApplicantSt. Jude Medical, Inc.
177 E. County Rd. B E.
St Paul, MN 55117
PMA NumberP970030
Supplement NumberS003
Date Received12/09/1999
Decision Date01/06/2000
Withdrawal Date05/14/2012
Product Code LWR 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Six manufacturing process chemical solution changes used in the production of the St. Jude Medical Toronto SPV Valve.
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