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 Number3007683266
FEI Number3007683266
NameIVANTIS, INC.
Owner & OperatorIvantis, Inc.
Contact Address201 Technology Dr.
Irvine CA 92618 US
Official Correspondent
  • Helene Spencer
  • x-949-6009650-1301
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address38 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 Number3016075957
FEI Number3016075957
NameIVANTIS, INC.
Owner & OperatorIvantis, Inc.
Contact Address201 Technology Dr.
Irvine CA 92618 US
Official Correspondent
  • Helene Spencer
  • x-949-6009650-1301
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address201 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
DeviceDate
Ivantis, Inc.
Hydrus Microstent2021-01-07
IVANTIS, INC.
Hydrus® Microstent F000222020-02-07
Ivantis, Inc.
Hydrus Microstent2020-01-23
Ivantis, Inc.
Hydrus Microstent2019-12-13
Ivantis, Inc.
Hydrus Microstent2019-12-10
Ivantis, Inc.
Hydrus Microstent2019-10-08
IVANTIS, INC.
Hydrus Microstent2018-08-13
IVANTIS, INC.
Hydrus Microstent2018-08-13
Ivantis, Inc.
HYDRUS MICROSTENT2018-08-10
IVANTIS, INC.
Hydrus Aqueous Implant2011-07-05
IVANTIS, INC.
Hydrus Aqueous Implant2011-07-05

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