AMVISC/AMVISC PLUS OVDS
FDA premarket approval P810025/S031 · decided 2012-07-27
Approval details
- PMA number
- P810025
- Supplement
- S031
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- AMVISC/AMVISC PLUS OVDS
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 2012-06-27
- Decision date
- 2012-07-27
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR MODIFICATIONS TO THE DIRECTIONS FOR USE TO INSTRUCT THE END-USER TO VERIFY THE CONNECTION OF THE CANNULA TO THE SYRINGE LUER.
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