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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 Clip Delivery System, MitraClip XTR Clip Delivery System, and MitraClip G4 Clip Delivery System
Generic NameMitral valve repair devices
ApplicantABBOTT MEDICAL
177 County Rd. B E.
St. Paul, MN 55117
PMA NumberP100009
Supplement NumberS037
Date Received01/31/2020
Decision Date02/26/2020
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  
Modification to the bonding process of the radiopaque ring and Delivery Catheter shaft of the MitraClip NTR/XTR and G4 Clip Delivery Systems.
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