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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.
 
DeviceMitraClip™ NTR/XTR Clip Delivery System, MitraClip™ G4 Clip Delivery System
Generic NameMitral valve repair devices
ApplicantABBOTT MEDICAL
177 County Rd. B E.
St. Paul, MN 55117
PMA NumberP100009
Supplement NumberS064
Date Received03/15/2024
Decision Date04/09/2024
Product Code NKM 
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  
use of an additional sterilization line, aeration room, and pre-existing preconditioning room to increase sterilization capacity at the currently approved contract sterilization facility
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