iStent inject® Trabecular Micro-Bypass System Model

FDA Premarket Approval P170043 S012

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

A change to the sampling plan for limulus amebocyte lysate (lal) endotoxin testing

• Device: iStent inject® Trabecular Micro-Bypass System Model
• Generic Name: Intraocular Pressure Lowering Implant
• Applicant: Glaukos Corporation
• Date Received: 2022-02-04
• Decision Date: 2022-02-18
• PMA: P170043
• Supplement: S012
• Product Code: OGO
• Advisory Committee: Ophthalmic
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: Glaukos Corporation 229 Avenida Fabricante san Clemente, CA 92672

Supplemental Filings

Supplement Number	Date	Supplement Type
P170043		Original 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 ID	PMA	Supp
00853704002203	P170043	000
00853704002319	P170043	005