OCUCOAT
FDA premarket approval P860047/S019 · decided 2006-12-21
Approval details
- PMA number
- P860047
- Supplement
- S019
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Express GMP Supplement
- Trade name
- OCUCOAT
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 2006-01-24
- Decision date
- 2006-12-21
- Days to decision
- 331 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT 8500 HIDDEN RIVER PARKWAY, TAMPA, FLORIDA.
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