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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™ Transcatheter Pulmonary Valve
ApplicantMedtronic, Inc.
3576 Unocal Pl.
Bldg. A
Santa Rosa, CA 95403
PMA NumberP200046
Supplement NumberS020
Date Received09/05/2023
Decision Date09/19/2023
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  
Relocation of the alpha-amino oleic acid (AOA) solution formulation process from ISO Class 7 Controlled Environment Area (CEA) 31 to ISO Class 8 CEA 33.
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