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.
The center for devices and radiological health (cdrh) of the food and drug administration (fda) has completed its review of your premarket approval application (pma) 180-day supplement, which requested approval for updated labeling to reflect the post approval study. Based upon the information submitted, the pma supplement is approved.
| Device | prodisc C Total Disc Replacement |
| Classification Name | Prosthesis, Intervertebral Disc |
| Generic Name | Prosthesis, Intervertebral Disc |
| Applicant | Centinel Spine, LLC |
| Date Received | 2018-12-04 |
| Decision Date | 2019-05-31 |
| PMA | P070001 |
| Supplement | S017 |
| Product Code | MJO |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Centinel Spine, LLC 900 Airport Road, Suite 3b west Chester, PA 19380 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P070001 | Original Filing | |
| S021 | 2021-09-21 | 30-day Notice |
| S020 | 2021-01-28 | 30-day Notice |
| S019 | ||
| S018 | 2019-06-21 | Normal 180 Day Track No User Fee |
| S017 | 2018-12-04 | Normal 180 Day Track No User Fee |
| S016 | 2017-09-20 | 30-day Notice |
| S015 | 2017-06-30 | 30-day Notice |
| S014 | ||
| S013 | 2014-04-03 | 135 Review Track For 30-day Notice |
| S012 | 2012-03-13 | 135 Review Track For 30-day Notice |
| S011 | 2011-07-19 | 30-day Notice |
| S010 | 2011-07-18 | 135 Review Track For 30-day Notice |
| S009 | 2010-08-02 | Real-time Process |
| S008 | 2010-06-07 | 30-day Notice |
| S007 | 2010-06-02 | 30-day Notice |
| S006 | 2010-05-27 | 30-day Notice |
| S005 | 2010-05-27 | 135 Review Track For 30-day Notice |
| S004 | 2010-05-19 | Normal 180 Day Track No User Fee |
| S003 | ||
| S002 | 2008-03-12 | Normal 180 Day Track No User Fee |
| S001 | 2008-01-31 | Real-time Process |