This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the sharpx(tm) needle destruction unit. The device is indicated for the destruction of 19 to 27 gauge hypodermic needles up to two inches in length. The unit is for use by healthcare professionals in out-patient and in-patient treatment settings and clinical laboratoreis.
| Device | SHARPX |
| Generic Name | Sharps Needle Destruction Device |
| Applicant | INNOVATIVE MEDICAL SYSTEMS, INC. |
| Date Received | 1998-05-08 |
| Decision Date | 1998-08-06 |
| Notice Date | 1998-09-17 |
| PMA | P980015 |
| Supplement | S |
| Product Code | MTV |
| Docket Number | 98M-0679 |
| Advisory Committee | General Hospital |
| 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 |