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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 NumberS001
Date Received09/27/2024
Decision Date10/22/2024
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  
Approval to implement the following manufacturing changes to UNIFEYE and UNIPEXY Gas Delivery Systems: 1) Implementing a pre- and post-assembly weight verification for UNIFEYE and UNIPEXY Gas Delivery Systems; 2) Implementing weighing cradles for UNIFEYE and UNIPEXY Gas Delivery Systems; 3) Updating the fixture travel length for the UNIFEYE Gas Delivery System during the insertion of the mixture stop into the plunger body. A new calibrated distance gauge will be used to verify this travel length.
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