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

FDA Premarket Approval P170043 S014

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 Corporation229 Avenida Fabricantesan Clemente, CA 92672 PMA NumberP170043 Supplement NumberS014 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
PMAP170043
SupplementS014
Product CodeOGO 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressGlaukos Corporation
229 Avenida Fabricante
san Clemente, CA 92672 PMA NumberP170043 Supplement NumberS014 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 Approval Order Statement  
approval For An Alternate Supplier And Modifications To The Specifications And Incoming Receiving Testing For The Stearalkonium Heparin Coating Raw Material

Supplemental Filings

Supplement NumberDateSupplement Type
P170043Original Filing
S014 2022-05-31 Normal 180 Day Track
S013
S012 2022-02-04 30-day Notice
S011
S010 2021-06-15 Normal 180 Day Track
S009 2021-03-25 135 Review Track For 30-day Notice
S008 2020-12-07 Normal 180 Day Track No User Fee
S007 2020-03-03 Normal 180 Day Track No User Fee
S006 2020-03-03 Normal 180 Day Track No User Fee
S005
S004 2019-05-02 30-day Notice
S003
S002 2018-07-23 Normal 180 Day Track No User Fee
S001 2018-07-23 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
00853704002203 P170043 000
00853704002319 P170043 005

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