PMA P990023S011
- Device
- CELLUGEL
- Applicant
- Alcon Laboratories
- PMA number
- P990023
- Supplement
- S011
- Product code
- LZP
- Decision date
- 2011-05-18
- 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
- CELLUGEL
- Applicant
- Alcon Laboratories
- PMA number
- P990023
- Supplement
- S011
- 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.