Ivantis Inc

FDA Filings

This page includes the latest FDA filings for Ivantis Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3007683266
• FEI Number: 3007683266
• Name: IVANTIS, INC.
• Owner & Operator: Ivantis, Inc.
• Contact Address: 201 Technology Dr. ; Irvine CA 92618 US
• Official Correspondent:
  • Helene Spencer
  • x-949-6009650-1301
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 38 Discovery Ste 150 ; Irvine, CA 92618 US
• Establishment Type:
  • Manufacture Device in the United States for Export Only
  • Complaint File Establishment per 21 CFR 820.198

• Registration Number: 3016075957
• FEI Number: 3016075957
• Name: IVANTIS, INC.
• Owner & Operator: Ivantis, Inc.
• Contact Address: 201 Technology Dr. ; Irvine CA 92618 US
• Official Correspondent:
  • Helene Spencer
  • x-949-6009650-1301
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 201 Technology Dr. ; Irvine, CA 92618 US
• Establishment Type:
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Device in the United States for Export Only

FDA Filings

Device Company	Device	Date
PMA P170034S007 Ivantis, Inc.	Hydrus® Microstent	2021-11-30
PMA P170034S006 Ivantis, Inc.	Hydrus Microstent	2021-01-07
GUDID 20867487000138 IVANTIS, INC.	Hydrus® Microstent F00022	2020-02-07
PMA P170034S004 Ivantis, Inc.	Hydrus Microstent	2020-01-23
PMA P170034S003 Ivantis, Inc.	Hydrus Microstent	2019-12-13
PMA P170034S002 Ivantis, Inc.	Hydrus Microstent	2019-12-10
PMA P170034S001 Ivantis, Inc.	Hydrus Microstent	2019-10-08
PMN P170034 | OGO IVANTIS, INC.	Hydrus Microstent	2018-08-13
PMN P170034 | OGO IVANTIS, INC.	Hydrus Microstent	2018-08-13
PMA P170034 Ivantis, Inc.	HYDRUS MICROSTENT	2018-08-10
OGO IVANTIS, INC.	Hydrus Aqueous Implant	2011-07-05
OGO IVANTIS, INC.	Hydrus Aqueous Implant	2011-07-05

Related Finance Registrations

NCAGE Code	88B03	IVANTIS, INC.
NCAGE Code	455X7	IVANTIS INC
CAGE Code	455X7	IVANTIS INC
CAGE Code	88B03	IVANTIS, INC.
S.A.M. Registration	88B03 [21154249]	IVANTIS, INC.
SEC	0001435678	IVANTIS INC of DELAWARE
SEC	0001521993	Ivantis, Inc. of DELAWARE