BVI 1%OVD (fonnerly BD 1%OVD and Biolon)
FDA premarket approval P960011/S028 · decided 2018-01-04
Approval details
- PMA number
- P960011
- Supplement
- S028
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BVI 1%OVD (fonnerly BD 1%OVD and Biolon)
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Altacor , Ltd.
- Date received
- 2017-12-07
- Decision date
- 2018-01-04
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Theale
- Statement
- Alternative, additional supplier for syringe components, and a tamper-evident tip cap closure system for the BVI 1% OVD®.
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