BIOLON 1% SODIUM HYALURONATE
FDA premarket approval P960011/S011 · decided 2007-09-13
Approval details
- PMA number
- P960011
- Supplement
- S011
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BIOLON 1% SODIUM HYALURONATE
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Altacor , Ltd.
- Date received
- 2006-09-18
- Decision date
- 2007-09-13
- Days to decision
- 360 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Theale
- Statement
- APPROVAL FOR A CHANGE IN INFLAMMATION TESTING FOR BULK SODIUM HYALURONATE FROM OXIDATIVE BURST TESTING TO AN IL-6 ELISA METHOD.
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