- Device
- UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy
- Applicant
- Alcon Research, LLC
- PMA number
- P230012
- Supplement
- S004
- Product code
- LPO
- Generic name
- Gases used within eye to place pressure on detached retina
- Decision date
- 2025-02-14
- Decision code
- OK30
- Date received
- 2025-01-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Ethylene Oxide sterilization specification is changed from 10 a pallet load configuration to a range of 1-10 pallet load configurations