BIOLON 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY
FDA premarket approval P960011/S004 · decided 2001-03-23
Approval details
- PMA number
- P960011
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BIOLON 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Altacor , Ltd.
- Date received
- 2000-04-11
- Decision date
- 2001-03-23
- Days to decision
- 346 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Theale
- Statement
- APPROVAL FOR CIBA VISION TO MARKET BIOLON(TM) 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY IN THE UNITED STATES UNDER THE TRADE NAME "UNIVISC".
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