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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameHANCOCK MODIFIED ORIFICE PORCINE BIOPROSTHETIC HEART VALVE
Classification Nameheart-valve, non-allograft tissue
Generic Nameheart valve
ApplicantMEDTRONIC CARDIAC SURGERY, MEDTRONIC, INC.
PMA NumberP790007
Supplement NumberS014
Date Received04/06/1998
Decision Date08/20/1998
Product Code
LWR[ Registered Establishments with LWR ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate polyester for use in the sewing ring ofthe three heart valves.
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