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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 and G4 Clip Delivery System
Generic NameMitral valve repair devices
ApplicantAbbott Medical
177 Country Road B East
St. Paul, MN 55117
PMA NumberP100009
Supplement NumberS035
Date Received08/19/2019
Decision Date09/11/2019
Product Code NKM 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Several modifications to component suppliers, test methods, and inspections.
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