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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.
 
DeviceCyPass Ultra System
Generic NameIntraocular pressure lowering implant
ApplicantAlcon Research, Ltd
6201 South Freeway
Fort Worth, TX 76134
PMA NumberP150037
Supplement NumberS010
Date Received06/25/2018
Decision Date07/23/2018
Product Code OGO 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Addition of the Sinking Spring, PA facility as an alternative manufacturing site for the CyPass Ultra System and implement changes to the inspection test methods and acceptance criteria for the stent delivery system.
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