Glaukos Corp San Clemente

FDA Filings

This page includes the latest FDA filings for Glaukos Corp San Clemente. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3012833022
• FEI Number: 3012341472
• Name: GLAUKOS CORP. San Clemente
• Owner & Operator: GLAUKOS CORP.
• Contact Address: 229 Avenida Fabricante --; San Clemente CA 92672 US
• Official Correspondent:
  • David - Fernquist
  • x-949-4810100-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 229 Avenida Fabricante ; San Clemente, CA 92672 US
• Establishment Type:
  • Manufacture Device in the United States for Export Only
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
PMN P170043 | OGO GLAUKOS CORP. San Clemente [GLAUKOS CORP.]	iStent inject	2018-06-22
HNN GLAUKOS CORP. San Clemente [GLAUKOS CORP.]	iAxis	2018-02-05
HNH GLAUKOS CORP. San Clemente [GLAUKOS CORP.]	iprism CLIP	2017-12-11
PMN P080030 | OGO GLAUKOS CORP. San Clemente [GLAUKOS CORP.]	iStent Trabecular Micro-Bypass Stent System	2016-10-14
OGO GLAUKOS CORP. San Clemente [GLAUKOS CORP.]	iStent supra	2009-04-17
OGO GLAUKOS CORP. San Clemente [GLAUKOS CORP.]	iStent inject W	2009-04-17
OGO GLAUKOS CORP. San Clemente [GLAUKOS CORP.]	iStent infinite iS3	2009-04-17

Similar & Related FDA Registered Companies

• Glaukos 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