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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 Micro-Stent
Generic Nameintraocular pressure lowering implant
Applicant
Alcon Research, Ltd
6201 south freeway
fort worth, TX 76134
PMA NumberP150037
Supplement NumberS014
Date Received12/20/2019
Decision Date04/09/2020
Product Code OGO 
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval study protocol - ode/oir
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the letter dated October 10, 2019 requesting that you continue the assessment of subjects implanted with the device for a minimum of 10 years to assess the long-term safety profile of the CyPass® System.
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