- Device
- AMVISC AND AMVISC PLUS OPHTHALMIC VISCOSURICAL DEVICE (OVD)
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P810025
- Supplement
- S033
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2013-04-24
- Decision code
- OK30
- Date received
- 2013-03-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADD AN ALTERNATE SITE FOR ITS WORKING CELL BANK MANUFACTURER, ADD AN ALTERNATE VITAMIN SUPPLIER AND CHANGE SOURCED CHEMICALS TO USP GRADE.