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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 CLIP DELIVERY SYSTEM
Generic NameMitral valve repair devices
ApplicantABBOTT MEDICAL
177 County Rd. B E.
St. Paul, MN 55117
PMA NumberP100009
Supplement NumberS018
Date Received05/11/2016
Decision Date08/09/2016
Product Code NKM 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a design change to the Actuator Slider component of the delivery system.
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