PMA P810025S031
- Device
- AMVISC/AMVISC PLUS OVDS
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P810025
- Supplement
- S031
- Product code
- LZP
- Decision date
- 2012-07-27
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Approval order 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.
Current openFDA PMA Record#
- Device
- AMVISC/AMVISC PLUS OVDS
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P810025
- Supplement
- S031
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2012-07-27
- Decision code
- APPR
- Date received
- 2012-06-27
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order 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.