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 modifications of device and to the labeling. The modifications to the device were noted to include the addition of a charger base and modifications to the device housing, electrode assembly and filter.
| Device | SHARP NEEDLE DESTRUCTION UNIT |
| Generic Name | Sharps Needle Destruction Device |
| Applicant | INNOVATIVE MEDICAL SYSTEMS, INC. |
| Date Received | 1998-12-08 |
| Decision Date | 1998-12-14 |
| PMA | P980015 |
| Supplement | S001 |
| Product Code | MTV |
| Advisory Committee | General Hospital |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | INNOVATIVE MEDICAL SYSTEMS, INC. 3610 Oakdale Drive mountain Brook, AL 35223 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P980015 | Original Filing | |
| S005 | 2002-05-30 | Real-time Process |
| S004 | 2001-07-16 | Special (immediate Track) |
| S003 | 1999-09-14 | Real-time Process |
| S002 | 1999-03-18 | Real-time Process |
| S001 | 1998-12-08 | Real-time Process |