iStent Trabecular Micro-Bypass Stent System, iStent inject Trabecular Micro-Bypass System, iStent inject W Trabecular Mi

FDA Premarket Approval P080030 S024

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

DeviceiStent Trabecular Micro-Bypass Stent System, iStent inject Trabecular Micro-Bypass System, iStent inject W Trabecular Mi
Generic NameIntraocular Pressure Lowering Implant
ApplicantGLAUKOS, CORPORATION26051 Merit Circle, Suite 103laguna Hills, CA 92653 PMA NumberP080030 Supplement NumberS024 Date Received05/31/2022 Decision Date08/29/2022 Product Code OGO  Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-05-31
Decision Date2022-08-29
PMAP080030
SupplementS024
Product CodeOGO 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressGLAUKOS, CORPORATION
26051 Merit Circle, Suite 103
laguna Hills, CA 92653 PMA NumberP080030 Supplement NumberS024 Date Received05/31/2022 Decision Date08/29/2022 Product Code OGO  Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo

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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