AMVISC & AMVISC PLUS
FDA premarket approval P810025/S028 · decided 2012-05-15
Approval details
- PMA number
- P810025
- Supplement
- S028
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AMVISC & AMVISC PLUS
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 2010-06-21
- Decision date
- 2012-05-15
- Days to decision
- 694 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR AN ALTERNATE RAW MATERIAL SOURCE (LIFECORES FERMENTATION-BASED SODIUM HYALURONATE) AND ALTERNATE MANUFACTURING SITE (LIFECORE BIOMEDICAL, LLC, CHASKA, MN) FOR RAW MATERIAL AND FINISHED PRODUCTS.
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