- Device
- OXYSEPT 1 & ULTRACARE DISINFECTING SOLUTIONS & OXYSEPT 2 NEUTRALIZING SOLUTION
- Applicant
- Advanced Medical Optics, Inc.
- PMA number
- P850088
- Supplement
- S033
- Product code
- LPN
- Generic name
- Accessories, soft lens products
- Decision date
- 1996-04-12
- Decision code
- APPR
- Date received
- 1995-05-05
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR ISOTRON IRELAND, LTD. LOCATED AT SRAGH INDUSTRIAL ESTATE, TULLAMORE, CO. OFFALY, IRELAND, AS AN ALTERNATE CONTRACT STERILIZATION SITE, AND FOR THE USE OF 100% ETHYLENE OXIDE TO STERILIZE THE PLASTIC BOTTLES, TIPS, AND CAPS