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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.
 
Trade NameCOFLEX INTERLAMINAR STABILIZATION DEVICE
Classification Nameprosthesis, spinous process spacer/plate
ApplicantPARADIGM SPINE, LLC
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 
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