BIOBRANE (R) II BLUE LABEL PRODUCT
FDA premarket approval P870069/S003 · decided 1991-02-22
Approval details
- PMA number
- P870069
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BIOBRANE (R) II BLUE LABEL PRODUCT
- Generic name
- Dressing, wound, drug
- Applicant
- Udl Laboratories, Inc.
- Date received
- 1990-12-03
- Decision date
- 1991-02-22
- Days to decision
- 81 days
- Decision code
- APPR
- Product code
- FRO
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Sugar Land, TX
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