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.
| Device | BIOBRANE (R) II BLUE LABEL PRODUCT |
| Classification Name | Dressing, Wound, Drug |
| Generic Name | Dressing, Wound, Drug |
| Applicant | UDL LABORATORIES, INC. |
| Date Received | 1990-12-03 |
| Decision Date | 1991-02-22 |
| PMA | P870069 |
| Supplement | S003 |
| Product Code | FRO |
| 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 | UDL LABORATORIES, INC. 12720 Dairy Ashford sugar Land, TX 77478 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P870069 | Original Filing | |
| S003 | 1990-12-03 | Normal 180 Day Track |
| S002 | ||
| S001 | 1989-11-14 | Normal 180 Day Track |