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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.
 
DeviceHydrus® Microstent
Generic NameIntraocular pressure lowering implant
ApplicantAlcon Research, LLC
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP170034
Supplement NumberS011
Date Received08/30/2023
Decision Date08/28/2024
Product Code OGO 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for a manufacturing site located at Alcon Research, LLC, 714 Columbia Avenue, Sinking Spring, PA 19608, for incoming acceptance activities, component cleaning, assembly, in-process acceptance activities, label printing, packaging, final acceptance activities, bioburden and bacterial endotoxin (BET) testing and a manufacturing site located at Steris AST, 23 Elizabeth Drive, Chester, NY 10918, for gamma irradiation sterilization of the Hydrus Microstent
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