BIOLON 1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID
FDA premarket approval P960011 · decided 1998-07-16
Approval details
- PMA number
- P960011
- Trade name
- BIOLON 1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Altacor , Ltd.
- Date received
- 1996-05-01
- Decision date
- 1998-07-16
- Days to decision
- 806 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Theale
- Statement
- The device is indicated for use as a surgical aid to protect corneal endothelium during cataract extraction (extra-capsular), intraocular lens implantation and anterior segment surgery.
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