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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Nameprosthesis, spinous process spacer/plate
Generic Nameprosthesis, spinous process spacer/plate
505 park avenue, 14th floor
new york, NY 10022
PMA NumberP110008
Date Received03/03/2011
Decision Date10/17/2012
Product Code
NQO[ Registered Establishments with NQO ]
Docket Number 12M-1085
Notice Date 11/08/2012
Advisory Committee Orthopedic
Clinical Trials NCT00534235
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the coflex interlaminar technology. This device is indicated for use in one- or two-level lumbar stenosis from l1- l5 in skeletally mature patients with at least moderate impairment in function, who experience relief in flexion from their symptoms of leg/buttocks/ groin pain, with or without back pain, and who have undergone at least 6 month of non-operative treatment. The coflex is intended to be implanted midline between adjacent lamina of 1 or 2 contiguous lumbar motion segments. Interlaminar stabilization is performed after decompression of stenosis at the affected level(s).
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005