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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
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 NumberS002
Date Received11/26/2013
Decision Date01/28/2014
Product Code
NKM[ Registered Establishments with NKM ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval study protocol - osb
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the post-approval study protocol.
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