BVI 1% OVD (1% sodium hyaluronate viscoelastic surgical aid fluid)
FDA premarket approval P960011/S027 · decided 2018-01-02
Approval details
- PMA number
- P960011
- Supplement
- S027
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BVI 1% OVD (1% sodium hyaluronate viscoelastic surgical aid fluid)
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Altacor , Ltd.
- Date received
- 2017-12-06
- Decision date
- 2018-01-02
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Theale
- Statement
- Increasing the formulation capacity for the manufacturing of BVI 1% OVD®.
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