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.
| Device | SCOLITRON(TM) STIMULATOR |
| Generic Name | Stimulator, Functional Neuromuscular, Scoliosis |
| Applicant | EBI, L.P. |
| Date Received | 1987-01-16 |
| Decision Date | 1987-04-02 |
| PMA | P820008 |
| Supplement | S005 |
| Product Code | LWB |
| Advisory Committee | Physical Medicine |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | EBI, L.P. 399 Jefferson Road parsippany, NJ 07054 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P820008 | Original Filing | |
| S005 | 1987-01-16 | Normal 180 Day Track |
| S004 | 1986-10-10 | Normal 180 Day Track |
| S003 | 1985-07-01 | |
| S002 | 1985-09-03 | |
| S001 | 1983-01-17 |