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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 I LOW POROSITY AND MODIFIED ORIFICE VALVED CONDUIT MODEL 150
Classification Nameheart-valve, non-allograft tissue
Generic Nameheart valve
Applicant MEDTRONIC INC.
PMA NumberP790007
Supplement NumberS028
Date Received10/21/2010
Decision Date11/19/2010
Product Code
LWR[ Registered Establishments with LWR ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Addition of a new tissue supplier.
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