- Device
- AMO(R) VITRAX(R) VISCOELASTIC SOLUTION
- Applicant
- Abbott Medical Optics, Inc.
- PMA number
- P880031
- Supplement
- S009
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 1996-04-09
- Decision code
- APPR
- Date received
- 1995-10-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- NEW STERILIZATION SITE AT GRIFFITH MICRO SCIENCE IN GLEN FALLS, NEW YORK AND A NEW STERILIZATION PROCESS, 100% ETHYLENE OXIDE, FOR AMO VITRAX (SODIUM HYALURONATE) IN FINAL PACKAGING