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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 MODIFIED ORIFICE PORCINE BIOPROSTHETIC HEART VALVE
Generic Nameheart-valve, non-allograft tissue
ApplicantMedtronic Heart Valves
1851 E. Deere Ave.
Santa Ana, CA 92705
PMA NumberP790007
Supplement NumberS014
Date Received04/06/1998
Decision Date08/20/1998
Product Code LWR 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for an alternate polyester for use in the sewing ring ofthe three heart valves.
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