BIOLON 1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID
FDA premarket approval P960011/S001 · decided 1998-09-09
Approval details
- PMA number
- P960011
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BIOLON 1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Altacor , Ltd.
- Date received
- 1998-08-31
- Decision date
- 1998-09-09
- Days to decision
- 9 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Theale
- Statement
- Approval for Akorn, Inc. to distribute BioLon(TM) in the United States.
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