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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.
 
DeviceHANCOCK II PORCINE BIOPROSTHESIS, MODELS T505 AND T510
Generic Namereplacement Heart-valve
Regulation Number870.3925
ApplicantMedtronic, Inc.
1851 E. Deere Ave.
Santa Ana, CA 92705
PMA NumberP980043
Supplement NumberS015
Date Received11/13/2007
Decision Date12/12/2007
Product Code DYE 
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 THE ADDITION OF A CAUTION STATEMENT TO THE LABELING.
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