BVI 1% OVD (formerly BD 1% OVD and Biolon)
FDA premarket approval P960011/S029 · decided 2018-03-15
Approval details
- PMA number
- P960011
- Supplement
- S029
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- BVI 1% OVD (formerly BD 1% OVD and Biolon)
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Altacor , Ltd.
- Date received
- 2018-02-12
- Decision date
- 2018-03-15
- Days to decision
- 31 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Theale
- Statement
- Approval for revisions to the labeling trade name from BVI 1% OVD® (1% sodium hyaluronate viscoelastic surgical aid fluid) to BIOLON, distributor, and Instructions for Use for the inclusion of a tamper-evident tip cap closure system.
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