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.
Approval of changes to the protocol for the post-approval study (pas) protocol.
| Device | COFLEX INTERLAMINAR TECHNOLOGY |
| Classification Name | Prosthesis, Spinous Process Spacer/plate |
| Generic Name | Prosthesis, Spinous Process Spacer/plate |
| Applicant | PARADIGM SPINE, LLC |
| Date Received | 2016-10-18 |
| Decision Date | 2017-03-10 |
| PMA | P110008 |
| Supplement | S007 |
| Product Code | NQO |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Osb |
| 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 |