This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
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).
| Device | COFLEX® INTERLAMINAR TECHNOLOGY |
| Classification Name | Prosthesis, Spinous Process Spacer/plate |
| Generic Name | Prosthesis, Spinous Process Spacer/plate |
| Applicant | PARADIGM SPINE, LLC |
| Date Received | 2011-03-03 |
| Decision Date | 2012-10-17 |
| Notice Date | 2012-11-08 |
| PMA | P110008 |
| Supplement | S |
| Product Code | NQO |
| Docket Number | 12M-1085 |
| Advisory Committee | Orthopedic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | PARADIGM SPINE, LLC 505 Park Avenue, 14th Floor new York, NY 10022 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P110008 | Original Filing | |
| S013 | 2021-01-06 | Normal 180 Day Track No User Fee |
| S012 | 2020-07-09 | Special (immediate Track) |
| S011 | 2019-10-29 | Normal 180 Day Track No User Fee |
| S010 | 2017-08-17 | Normal 180 Day Track No User Fee |
| S009 | 2017-07-03 | Normal 180 Day Track No User Fee |
| S008 | 2017-06-26 | Normal 180 Day Track |
| S007 | 2016-10-18 | Normal 180 Day Track No User Fee |
| S006 | 2016-09-01 | Real-time Process |
| S005 | 2016-03-09 | Normal 180 Day Track No User Fee |
| S004 | 2016-01-14 | 30-day Notice |
| S003 | 2014-02-19 | Normal 180 Day Track No User Fee |
| S002 | 2012-11-26 | Normal 180 Day Track No User Fee |
| S001 | 2012-11-26 | Normal 180 Day Track No User Fee |