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 the prestige lp cervical disc. This device is indicated in skeletally mature patients for reconstruction of the disc from c3-c7 following discectomy at one level or two contiguous levels for intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain, or myelopathy due to abnormality localized to the level of the disc space and at least one of the following conditions confirmed by imaging (ct, mri, x-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels. The prestige lp™ cervical disc is implanted using an anterior approach. Patients should have failed at least 6 weeks of non-operative treatment or have had the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative management prior to implantation of the prestige lp cervical disc.
| Device | PRESTIGE LP(TM) CERVICAL DISC |
| Classification Name | Prosthesis, Intervertebral Disc |
| Generic Name | Prosthesis, Intervertebral Disc |
| Applicant | Medtronic Sofamor Danek USA, Inc. |
| Date Received | 2015-06-03 |
| Decision Date | 2016-07-07 |
| Notice Date | 2016-07-25 |
| PMA | P090029 |
| Supplement | S003 |
| Product Code | MJO |
| Docket Number | 16M-2182 |
| Advisory Committee | Orthopedic |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place memphis, TN 38132 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P090029 | Original Filing | |
| S015 | 2020-10-21 | 30-day Notice |
| S014 | 2020-03-18 | 30-day Notice |
| S013 | 2019-09-26 | Normal 180 Day Track No User Fee |
| S012 | 2019-05-23 | Normal 180 Day Track No User Fee |
| S011 | 2018-10-31 | Normal 180 Day Track No User Fee |
| S010 | 2018-09-18 | Special (immediate Track) |
| S009 | 2017-12-11 | Normal 180 Day Track No User Fee |
| S008 | 2017-07-13 | Normal 180 Day Track No User Fee |
| S007 | 2016-12-22 | Normal 180 Day Track |
| S006 | 2016-08-05 | Normal 180 Day Track No User Fee |
| S005 | 2016-07-11 | 30-day Notice |
| S004 | 2015-09-02 | Normal 180 Day Track No User Fee |
| S003 | 2015-06-03 | Panel Track |
| S002 | 2014-08-22 | Normal 180 Day Track No User Fee |
| S001 | 2014-08-08 | Normal 180 Day Track No User Fee |