AMVISC/AMVISC PLUS SODIUM HYALURONATE
FDA premarket approval P810025/S020 · decided 2002-07-19
Approval details
- PMA number
- P810025
- Supplement
- S020
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- AMVISC/AMVISC PLUS SODIUM HYALURONATE
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 2002-03-22
- Decision date
- 2002-07-19
- Days to decision
- 119 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR A NEW ASEPTIC MANUFACTURING SUITE LOCATED AT ANIKA THERAPEUTICS, INC., WOBURN, MASSACHUSETTS.
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