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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceUNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System
Generic NameGases used within eye to place pressure on detached retina
Regulation Number886.4270
ApplicantAlcon Research, LLC
20511 Lake Forest Dr.
Lake Forest, CA 92630
PMA NumberP230012
Supplement NumberS011
Date Received05/05/2026
Decision Date05/28/2026
Product Code LPO 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
addition of a UNIFEYE nose piece bonding fixture used on the UNIFEYE check valve subassembly during the bonding and curing processes, changing from a manual to an automated torque test fixture to verify the bonding; and updating to the torque test method used during the UNIFEYE final assembly process for torque testing of the UNIFEYE check valve and mixture stop subassemblies.
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