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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 NumberS005
Date Received04/20/2017
Decision Date05/15/2017
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  
Additional supplier for the CyPass System Applier.
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