PMA P230012S002

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: S002
Product code: LPO
Decision date: 2024-12-02
Classification: Ophthalmic
Generic name: Gases used within eye to place pressure on detached retina
Approval order statement: Approval to add Arrow Finishing as an alternate passivation process supplier for Picocyl for the piston subcomponent in the UNIFEYE and UNIPEXY Gas Delivery Systems.

Current openFDA PMA Record#

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: S002
Product code: LPO
Generic name: Gases used within eye to place pressure on detached retina
Decision date: 2024-12-02
Decision code: OK30
Date received: 2024-11-08
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval to add Arrow Finishing as an alternate passivation process supplier for Picocyl for the piston subcomponent in the UNIFEYE and UNIPEXY Gas Delivery Systems.