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 to exapnd the responsibilities of hammill medical (360 tomahawk drive maumee, oh 43537) to perform the following for the prodisc -c modified endplates (-sk, -novo, and -vivo) once the modified endplates are approved: acquire the raw material, machine the endplate components, polish the superior endplates, complete inspections and bead blast the endplates
| Device | prodisc® C |
| Generic Name | Prosthesis, Intervertebral Disc |
| Applicant | Centinel Spine, LLC |
| Date Received | 2021-09-21 |
| Decision Date | 2021-10-28 |
| PMA | P070001 |
| Supplement | S021 |
| Product Code | MJO |
| Advisory Committee | Orthopedic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process 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 |