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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 Delivery Catheter System (DCS) and Loading System
Generic Namepulmonary valve prosthesis percutaneously delivered
ApplicantMedtronic, Inc.
3576 unocal place
building a
santa rosa, CA 95403
PMA NumberP200046
Supplement NumberS003
Date Received05/17/2021
Decision Date01/27/2022
Product Code NPV 
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
Approval Order Statement  
Approval for using calculations of spore log resistance to evaluate lethality challenges of the requalification microbiological performance qualification for process development.
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