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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 NumberS015
Date Received05/12/1998
Decision Date10/30/1998
Product Code
LWR[ Registered Establishments with LWR ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for exemption from annual reporting on the post-market study for this device.
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