PMA P810025S034
- Device
- AMVISC 0.8 ML SYRINGE AND AMVISC PLUS, O.8 ML SYRINGE
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P810025
- Supplement
- S034
- Product code
- LZP
- Decision date
- 2013-08-13
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Approval order statement
- CHANGE IN THE EXISTING CLEAN ROOM INTO A FORMULATION ROOM.
Current openFDA PMA Record#
- Device
- AMVISC 0.8 ML SYRINGE AND AMVISC PLUS, O.8 ML SYRINGE
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P810025
- Supplement
- S034
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2013-08-13
- Decision code
- OK30
- Date received
- 2013-07-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE EXISTING CLEAN ROOM INTO A FORMULATION ROOM.