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 for additional cleaning, passivation and thermal rinse steps, and the following four (4) manufacturing sites, at the following addresses, and for the following purposes:centinel spine (manufacturer)900 airport road suite 3bwest chester, pa 19380hammill medical (contract manufacturer)360 tomahawk drivemaumee, oh 43537fruh verpackungstechnik ag (contract manufacturer)allmendstrasse 47fehraltoff switzerland 8320synergy health daniken ag (contract sterilizer)hogenweidstrasse 6daniken solothurn switzerland 4658
| Device | prodisc C Total Disc Replacement |
| Generic Name | Prosthesis, Intervertebral Disc |
| Applicant | Centinel Spine, LLC |
| Date Received | 2019-06-21 |
| Decision Date | 2020-05-08 |
| PMA | P070001 |
| Supplement | S018 |
| Product Code | MJO |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| 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 |