iStent inject W Trabecular Micro-Bypass System

FDA Premarket Approval P170043 S009

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 for an alternate manufacturing process and supplier for the singulator holder assembly.

DeviceiStent inject W Trabecular Micro-Bypass System
Generic NameIntraocular Pressure Lowering Implant
ApplicantGlaukos Corporation
Date Received2021-03-25
Decision Date2021-08-31
PMAP170043
SupplementS009
Product CodeOGO 
Advisory CommitteeOphthalmic
Supplement Type135 Review Track For 30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Glaukos Corporation 229 Avenida Fabricante san Clemente, CA 92672

Supplemental Filings

Supplement NumberDateSupplement Type
P170043Original Filing
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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