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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.
 
DeviceHanock II Bioprosthesis, Models T505 and T510
Generic Namereplacement Heart-valve
Regulation Number870.3925
ApplicantMedtronic, Inc.
1851 E. Deere Ave.
Santa Ana, CA 92705
PMA NumberP980043
Supplement NumberS059
Date Received03/24/2017
Decision Date06/30/2017
Product Code DYE 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the use of Covidien Medical Products (Shanghai) Manufacturing LLC located in Shanghai, China as an alternate manufacturing facility for the receiving and processing of raw tissue valve components used in the manufacture of Medtronic bioprosthetic valves.
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