PMA P990023S016
- Device
- CELLUGEL(R) OPHTHALMIC VISCOSURGICAL DEVICE
- Applicant
- Alcon Laboratories
- PMA number
- P990023
- Supplement
- S016
- Product code
- LZP
- Decision date
- 2016-09-09
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Approval order statement
- Approval to replace the current product release intravitreal test with the inflammatory release assay (IRA) product release test.
Current openFDA PMA Record#
- Device
- CELLUGEL(R) OPHTHALMIC VISCOSURGICAL DEVICE
- Applicant
- Alcon Laboratories
- PMA number
- P990023
- Supplement
- S016
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2016-09-09
- Decision code
- APPR
- Date received
- 2016-06-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to replace the current product release intravitreal test with the inflammatory release assay (IRA) product release test.