AMVISC AND AMVISC PLUS SODIUM HYALURONATE VISCOELASTICS
FDA premarket approval P810025/S021 · decided 2002-12-03
Approval details
- PMA number
- P810025
- Supplement
- S021
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AMVISC AND AMVISC PLUS SODIUM HYALURONATE VISCOELASTICS
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 2002-05-10
- Decision date
- 2002-12-03
- Days to decision
- 207 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR A BUFFERED FORMULATION (PH 6.8 - 7.6) FOR AMVISC AND AMVISC PLUS SODIUM HYALURONATE VISCOELASTICS.
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