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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 SYSTEM
Generic NameIntraocular pressure lowering implant
ApplicantAlcon Research, Ltd
6201 South Freeway
Fort Worth, TX 76134
PMA NumberP150037
Supplement NumberS002
Date Received08/26/2016
Decision Date03/15/2017
Product Code OGO 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol - OSB
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval of the protocol for the post-approval study (PAS) protocol.
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