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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 BIOPROSTHESIS MODEL 250
Classification Nameheart-valve, non-allograft tissue
Generic Nameheart valve
ApplicantTHE HEART VALVE DIV. MEDTRONIC CARDIOVASCULAR SURG
PMA NumberP790007
Supplement NumberS012
Date Received04/12/1993
Decision Date12/08/1993
Product Code
LWR[ Registered Establishments with LWR ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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