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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.
 
DeviceAvalus™ Bioprosthesis
Generic Nameheart-valve, non-allograft tissue
ApplicantMedtronic, Inc.
1851 E. Deere Ave.
Santa Ana, CA 92705
PMA NumberP170006
Supplement NumberS027
Date Received09/12/2023
Decision Date09/25/2023
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  
New sterilization cycle for moist heat sterilization of the primary packaging for the Evolut R, PRO, PRO+, FX Transcatheter Aortic Valves (TAV), the Harmony and Melody Transcatheter Pulmonary Valves (TPV), and the Avalus Bioprosthesis manufactured in Tijuana, Mexico. Additionally, a new sterilization configuration for the primary packaging sterilization is also being introduced for the Evolut TAV jars and Harmony TPV jars.
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