PMA P990023S008
- Device
- CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE
- Applicant
- Alcon Laboratories
- PMA number
- P990023
- Supplement
- S008
- Product code
- LZP
- Decision date
- 2009-10-15
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Approval order statement
- ALTERNATE PROCESS TO AUTOMATE THE REVIEW AND DOCUMENTATION OF LABORATORY AND PROCESS TEST RESULTS AS PART OF THE ELECTRONIC BATCH RECORD (EBR) SYSTEM.
Current openFDA PMA Record#
- Device
- CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE
- Applicant
- Alcon Laboratories
- PMA number
- P990023
- Supplement
- S008
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2009-10-15
- Decision code
- OK30
- Date received
- 2009-09-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ALTERNATE PROCESS TO AUTOMATE THE REVIEW AND DOCUMENTATION OF LABORATORY AND PROCESS TEST RESULTS AS PART OF THE ELECTRONIC BATCH RECORD (EBR) SYSTEM.