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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™ G4 Clip Delivery System
Generic NameMitral valve repair devices
ApplicantABBOTT MEDICAL
177 County Rd. B E.
St. Paul, MN 55117
PMA NumberP100009
Supplement NumberS061
Date Received10/24/2023
Decision Date01/22/2024
Product Code NKM 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
• Change in the polyester yarn supplier of the Clip Cover• Change in raw material sub-supplier and source of Polypropylene resin material for the Cover reinforcement material• Change in the incoming quality inspection tolerance for a Clip Arm dimension, and• Change in the Stomper equipment setup control range.
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