This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Addition of a second supplier for the instruments with the following part numbers: uat00008, uat00010, uat00012, uat00014, uat00016, ubt10008, ubt10010, ubt10012, ubt10014, ubt10016, uat10100, uat10200, uat10300, uat20100, and uat20110.
| Device | coflex Interlaminar Technology |
| Classification Name | Prosthesis, Spinous Process Spacer/plate |
| Generic Name | Prosthesis, Spinous Process Spacer/plate |
| Applicant | PARADIGM SPINE, LLC |
| Date Received | 2016-01-14 |
| Decision Date | 2016-02-09 |
| PMA | P110008 |
| Supplement | S004 |
| Product Code | NQO |
| Advisory Committee | Orthopedic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | PARADIGM SPINE, LLC 505 Park Avenue, 14th Floor new York, NY 10022 |
| 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 |