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 change in the quality control procedures for post-sterilization lots of oxycel
| Device | OXYCELL |
| Generic Name | Agent, Absorbable Hemostatic, Non-collagen Based |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
| Date Received | 1995-02-16 |
| Decision Date | 1995-07-24 |
| PMA | N5798 |
| Supplement | S007 |
| Product Code | LMG |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC one Becton Dr. franklin Lakes, NJ 07417-1880 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| N5798 | Original Filing | |
| S007 | 1995-02-16 | Normal 180 Day Track |
| S006 | 1990-12-19 | Normal 180 Day Track |
| S005 | 1988-09-21 | Normal 180 Day Track |
| S004 | 1983-04-21 | |
| S003 | 1982-06-29 | |
| S002 | 1980-10-29 | |
| S001 | 1980-10-27 |