BVI 1% OVD-SODIUM HYALURONATE VISCOELASTIC
FDA premarket approval P960011/S018 · decided 2011-03-08
Approval details
- PMA number
- P960011
- Supplement
- S018
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- BVI 1% OVD-SODIUM HYALURONATE VISCOELASTIC
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Altacor , Ltd.
- Date received
- 2011-02-10
- Decision date
- 2011-03-08
- Days to decision
- 26 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Theale
- Statement
- APPROVAL FOR THE INCLUSION OF DIRECTIONS FOR PROPER FINGER FLANGE ORIENTATION IN THE INSTRUCTIONS FOR USE. IN ADDITIONAL APPROVAL TO CHANGE THE TRADE NAME OF THE DEVICE FROM BD 1% OVD SODIUM HYALURONATE TO BVI 1% OVD SODIUM HYALURONATE.
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