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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 Stent
Generic Nameintraocular pressure lowering implant
Applicant
Alcon Research, Ltd
6201 south freeway
fort worth, TX 76134
PMA NumberP150037
Supplement NumberS003
Date Received11/03/2016
Decision Date11/17/2016
Product Code OGO 
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Additional Controlled Environment Room (CER) at the approved CyPass manufacturing facility.
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