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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 NumberS013
Date Received10/10/2024
Decision Date01/30/2025
Product Code OGO 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for minor corrections to labeling that reflects the findings of the Post-Approval Study (PAS) designated as “Continuation of Premarket Cohort PAS” or P170034/PAS 001.
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