Change in the sealing parameters used in the sterile packaging process for the prodisc-l total disc replacement device.
| Device | ProDisc-L Total Disc Replacement |
| Classification Name | Prosthesis, Intervertebral Disc |
| Generic Name | Prosthesis, Intervertebral Disc |
| Applicant | Centinel Spine, LLC |
| Date Received | 2017-10-18 |
| Decision Date | 2017-11-15 |
| PMA | P050010 |
| Supplement | S019 |
| Product Code | MJO |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| 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 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P050010 | | Original Filing |
| S023 |
2021-03-01 |
30-day Notice |
| S022 |
2019-09-09 |
Real-time Process |
| S021 | | |
| S020 | | |
| S019 |
2017-10-18 |
30-day Notice |
| S018 | | |
| S017 |
2016-01-15 |
30-day Notice |
| S016 |
2014-04-03 |
135 Review Track For 30-day Notice |
| S015 | | |
| S014 |
2012-12-07 |
Normal 180 Day Track |
| S013 |
2012-11-08 |
Normal 180 Day Track No User Fee |
| S012 |
2011-04-26 |
Real-time Process |
| S011 |
2011-01-28 |
135 Review Track For 30-day Notice |
| S010 |
2010-09-29 |
135 Review Track For 30-day Notice |
| S009 |
2010-09-15 |
135 Review Track For 30-day Notice |
| S008 |
2010-08-02 |
Real-time Process |
| S007 |
2010-05-19 |
Normal 180 Day Track No User Fee |
| S006 |
2010-04-26 |
30-day Notice |
| S005 |
2010-04-26 |
30-day Notice |
| S004 | | |
| S003 |
2008-07-28 |
30-day Notice |
| S002 |
2008-05-29 |
135 Review Track For 30-day Notice |
| S001 |
2007-12-26 |
Real-time Process |
NIH GUDID Devices