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.
| Device | BIOBRANE(R) II |
| Classification Name | Dressing, Wound, Drug |
| Generic Name | Dressing, Wound, Drug |
| Applicant | UDL LABORATORIES, INC. |
| Date Received | 1987-11-12 |
| Decision Date | 1989-10-20 |
| Notice Date | 1989-12-06 |
| PMA | P870069 |
| Supplement | S |
| Product Code | FRO |
| Docket Number | 89M-0491 |
| Advisory Committee | General & Plastic Surgery |
| 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 |