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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
Classification Namemitral valve repair devices
Generic Namemitral valve repair devices
Applicant
ABBOTT VASCULAR INC.
4045 campbell avenue
menlo park, CA 94025
PMA NumberP100009
Supplement NumberS005
Date Received05/01/2014
Decision Date05/22/2014
Product Code
NKM[ Registered Establishments with NKM ]
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A LABELING CHANGE THAT INCLUDED ADDITIONS TO THE LIST OF ANTICIPATED EVENTS AND CONVERTING CERTAIN PROCEDURAL CAUTION STATEMENTS TO WARNING STATEMENTS.
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