PMA P220030S006

Device: UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery
Applicant: Alcon Research, LLC
PMA number: P220030
Supplement: S006
Product code: LPO
Decision date: 2025-04-30
Classification: Ophthalmic
Generic name: Gases used within eye to place pressure on detached retina
Approval order statement: The manufacturing changes to the in-process seal strength integrity testing methodology from peel testing to burst and dye testing is approved.

Current openFDA PMA Record#

Device: UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery
Applicant: Alcon Research, LLC
PMA number: P220030
Supplement: S006
Product code: LPO
Generic name: Gases used within eye to place pressure on detached retina
Decision date: 2025-04-30
Decision code: OK30
Date received: 2025-04-08
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: The manufacturing changes to the in-process seal strength integrity testing methodology from peel testing to burst and dye testing is approved.