AMVISC & AMVISC PLUS
FDA premarket approval P810025/S024 · decided 2004-07-16
Approval details
- PMA number
- P810025
- Supplement
- S024
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AMVISC & AMVISC PLUS
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 2004-06-24
- Decision date
- 2004-07-16
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- ELIMINATION OF THE OWL MONKEY TEST FOR INFLAMMATORY POTENTIAL OF BULK AND FINISHED PRODUCT FORMULATION OF AMVISC & AMVISC PLUS.
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