ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM

Intraocular Pressure Lowering Implant

FDA Premarket Approval P080030 S013

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.

Pre-market Approval Supplement Details

Approval to update your labeling to include the results of your post-approval study (pas) for the istent trabecular micro-bypass stent system, extended follow-up of the investigational device exemption (ide) cohort study.

DeviceISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM
Classification NameIntraocular Pressure Lowering Implant
Generic NameIntraocular Pressure Lowering Implant
ApplicantGLAUKOS, CORPORATION
Date Received2015-02-09
Decision Date2015-08-07
PMAP080030
SupplementS013
Product CodeOGO
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLabeling Change - Pas
Expedited ReviewNo
Combination Product No
Applicant Address GLAUKOS, CORPORATION 26051 Merit Circle, Suite 103 laguna Hills, CA 92653

Supplemental Filings

Supplement NumberDateSupplement Type
P080030Original Filing
S024 2022-05-31 Normal 180 Day Track
S023 2022-02-04 30-day Notice
S022 2018-11-21 30-day Notice
S021 2018-03-01 Normal 180 Day Track
S020 2017-02-13 Normal 180 Day Track
S019 2016-11-07 30-day Notice
S018 2015-12-15 Normal 180 Day Track No User Fee
S017 2015-05-26 Normal 180 Day Track No User Fee
S016 2015-05-22 Normal 180 Day Track No User Fee
S015
S014 2015-02-11 Real-time Process
S013 2015-02-09 Normal 180 Day Track No User Fee
S012 2014-09-30 Normal 180 Day Track
S011 2014-08-01 30-day Notice
S010 2013-07-30 30-day Notice
S009 2013-05-23 30-day Notice
S008 2013-04-05 30-day Notice
S007 2013-02-19 30-day Notice
S006 2012-08-21 30-day Notice
S005 2012-07-20 Normal 180 Day Track No User Fee
S004 2012-07-20 Normal 180 Day Track No User Fee
S003 2012-07-20 Normal 180 Day Track No User Fee
S002 2012-07-09 135 Review Track For 30-day Notice
S001 2012-06-29 135 Review Track For 30-day Notice

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