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 expansion of the needle gauge range to include 18-30 gauge needles, and minor labeling changes.
| Device | SHARPX NEEDLE DESTRUCTION UNIT |
| Generic Name | Sharps Needle Destruction Device |
| Applicant | INNOVATIVE MEDICAL SYSTEMS, INC. |
| Date Received | 2002-05-30 |
| Decision Date | 2002-06-12 |
| PMA | P980015 |
| Supplement | S005 |
| Product Code | MTV |
| Advisory Committee | General Hospital |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |