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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.
 
DeviceCOFLEX® INTERLAMINAR TECHNOLOGY
Classification Nameprosthesis, spinous process spacer/plate
Generic Nameprosthesis, spinous process spacer/plate
Applicant
PARADIGM SPINE, LLC
505 park avenue, 14th floor
new york, NY 10022
PMA NumberP110008
Supplement NumberS002
Date Received11/26/2012
Decision Date04/23/2013
Product Code
NQO[ Registered Establishments with NQO ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track no user fee
Supplement Reason other report
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the post-approval study.
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