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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.
 
Trade NameCOFLEX INTERLAMINAR TECHNOLOGY
Classification Nameprosthesis, spinous process spacer/plate
ApplicantPARADIGM SPINE, LLC
PMA NumberP110008
Supplement NumberS001
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 pas protocal supplement osb
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the post-approval study protocol.
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