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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceHANCOCK I LOW POROSITY AND MODIFIED ORIFICE VALVED CONDUIT, MODELS 105 AND 150
Generic Nameheart-valve, non-allograft tissue
ApplicantMedtronic Heart Valves
1851 E. Deere Ave.
Santa Ana, CA 92705
PMA NumberP790007
Supplement NumberS023
Date Received10/05/2009
Decision Date11/03/2009
Product Code LWR 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ADDITION OF ALTERNATE MATERIAL SUPPLIERS.
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