PMA P840064S046
- Device
- DISCOVISC, VISCOAT AND DUOVISC
- Applicant
- Alcon Laboratories
- PMA number
- P840064
- Supplement
- S046
- Product code
- LZP
- Decision date
- 2011-05-18
- Classification
- Aid, Surgical, Viscoelastic
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Approval order statement
- EXPAND THE ELECTRONIC BATCH RECORD SYSTEM TO INCLUDE ELECTRONIC DOCUMENTATION OF THE REACTOR/VESSEL CLEANING FOR OPHTHALMIC VISCOSURGICAL DEVICES.
Current openFDA PMA Record#
- Device
- DISCOVISC, VISCOAT AND DUOVISC
- Applicant
- Alcon Laboratories
- PMA number
- P840064
- Supplement
- S046
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2011-05-18
- Decision code
- OK30
- Date received
- 2011-04-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- EXPAND THE ELECTRONIC BATCH RECORD SYSTEM TO INCLUDE ELECTRONIC DOCUMENTATION OF THE REACTOR/VESSEL CLEANING FOR OPHTHALMIC VISCOSURGICAL DEVICES.