OCUCOAT (2% HYDROXPROPYLMETHYLCELLULOSE SOLUTION)
FDA premarket approval P860047/S024 · decided 2012-05-04
Approval details
- PMA number
- P860047
- Supplement
- S024
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OCUCOAT (2% HYDROXPROPYLMETHYLCELLULOSE SOLUTION)
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 2010-07-21
- Decision date
- 2012-05-04
- Days to decision
- 653 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT LIFECORE BIOMEDICAL, LLC IN CHASKA, MINNESOTA.
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