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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, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy
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 NumberS005
Date Received03/06/2025
Decision Date03/24/2025
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  
1. Add Arrow Finishing (Blaine, MN, USA), formerly known as Arrow Cryogenics, as an alternate passivation process supplier to Picocyl LLC for the pico-cylinder cap, can, and spring subcomponents.2. Add three alternate fabrication suppliers: - J&J Machining (Elk River, MN, USA) for the pico-cylinder piston subcomponent - Stueken (Fountain Inn, SC, USA) for the pico-cylinder cap and can subcomponents - Western Spring Manufacturing (Hugo, MN, USA) for the pico-cylinder spring subcomponent
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