PMA P810025S027
- Device
- AMVISC & AMVISC PLUS
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P810025
- Supplement
- S027
- Product code
- LZP
- Decision date
- 2012-06-14
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE CHANGE AND CHANGE IN TERMINAL STERILIZATION METHOD (I.E., E-BEAM TO VAPOR HYDROGEN PEROXIDE) OF THE PRODUCT.
Current openFDA PMA Record#
- Device
- AMVISC & AMVISC PLUS
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P810025
- Supplement
- S027
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2012-06-14
- Decision code
- APPR
- Date received
- 2009-05-27
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE CHANGE AND CHANGE IN TERMINAL STERILIZATION METHOD (I.E., E-BEAM TO VAPOR HYDROGEN PEROXIDE) OF THE PRODUCT.