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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 & MODIFIED ORIFICE VALVED CONDUIT
Classification Nameheart-valve, non-allograft tissue
Generic Nameheart valve
Applicant MEDTRONIC INC.
PMA NumberP790007
Supplement NumberS022
Date Received07/09/2009
Decision Date07/27/2009
Product Code
LWR[ Registered Establishments with LWR ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of an alternate supplier.
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