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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 Bioprostheses
Generic Nameheart-valve, non-allograft tissue
ApplicantMedtronic, Inc.
1851 E. Deere Ave.
Santa Ana, CA 92705
PMA NumberP170006
Supplement NumberS040
Date Received09/29/2025
Decision Date02/12/2026
Product Code LWR 
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 AuthorizedYes
Approval Order Statement  
approval for a Pre-Determined Change Control Plan (PCCP) that establishes a standardized qualification process for new bovine and porcine tissue suppliers, provided they do not impact the tissue's specifications, the established methods for its sourcing, handling, and testing, or the qualification standards for supplier facilities and personnel for the devices under the above PMAs
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