BIOLON 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY
FDA premarket approval P960011/S010 · decided 2005-09-15
Approval details
- PMA number
- P960011
- Supplement
- S010
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- BIOLON 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Altacor , Ltd.
- Date received
- 2005-05-11
- Decision date
- 2005-09-15
- Days to decision
- 127 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Theale
- Statement
- APPROVAL TO INCLUDE IOLTECH, CIDRA, PUERTO RICO AS A DISTRIBUTOR FOR BIOLON IN THE UNITED STATES.
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