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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 MODIFIED ORIFICE VALVED CONDUIT, MODEL 150
Generic Nameheart-valve, non-allograft tissue
ApplicantMedtronic Heart Valves
1851 E. Deere Ave.
Santa Ana, CA 92705
PMA NumberP790007
Supplement NumberS036
Date Received04/01/2013
Decision Date04/30/2013
Product Code LWR 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
INSTALLATION OF A NEW COMPRESSED AIR SYSTEM.
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