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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.
 
DeviceHarmony Transcathetrer Pulmonary Valve
Generic NamePulmonary valve prosthesis percutaneously delivered
ApplicantMedtronic, Inc.
3576 Unocal Pl.
Bldg. A
Santa Rosa, CA 95403
PMA NumberP200046
Supplement NumberS035
Date Received08/06/2024
Decision Date08/13/2024
Product Code NPV 
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  
the use of an electronic Manufacturing Execution System (MES) to replace the current paper-based device history record (DHR)
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