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 a modification of a contraindication statement in the labeling.
| Device | SHARP(X)TM NEEDLE DESTRUCTION UNIT |
| Generic Name | Sharps Needle Destruction Device |
| Applicant | INNOVATIVE MEDICAL SYSTEMS, INC. |
| Date Received | 1999-09-14 |
| Decision Date | 1999-09-17 |
| PMA | P980015 |
| Supplement | S003 |
| 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 |