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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, T510
Classification Namereplacement heart-valve
Generic Namereplacement heart-valve
Regulation Number870.3925
Applicant
Medtronic, Inc.
1851 east deere ave.
santa ana, CA 92705
PMA NumberP980043
Supplement NumberS029
Date Received10/21/2010
Decision Date11/19/2010
Product Code
DYE[ Registered Establishments with DYE ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
ADDITION OF A NEW TISSUE SUPPLIER.
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