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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 Ultra System
Generic Nameintraocular pressure lowering implant
Applicant
Alcon Research, Ltd
6201 south freeway
fort worth, TX 76134
PMA NumberP150037
Supplement NumberS008
Date Received09/25/2017
Decision Date12/18/2017
Product Code OGO 
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for design changes to the CyPass System 241-S and inclusion of an additional sterilization vendor. The modified design will be marketed as the CyPass Ultra System.
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