BIOLON 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY
FDA premarket approval P960011/S005 · decided 2000-05-19
Approval details
- PMA number
- P960011
- Supplement
- S005
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BIOLON 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Altacor , Ltd.
- Date received
- 2000-04-25
- Decision date
- 2000-05-19
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Theale
- Statement
- Sterility release be based on review of documentation of the ethylene oxide sterilization cycle and testing of the biological indicators and that external sterility testing of Biolon syringe surfaces be discontinued.
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