HYDRUS MICROSTENT

Intraocular Pressure Lowering Implant

FDA Premarket Approval P170034

Pre-market Approval Supplement Details

Approval for the hydrus® microstent. This device is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (iop) in adult patients with mild to moderate primary open-angle glaucoma (poag).

DeviceHYDRUS MICROSTENT
Classification NameIntraocular Pressure Lowering Implant
Generic NameIntraocular Pressure Lowering Implant
ApplicantIvantis, Inc.
Date Received2017-10-30
Decision Date2018-08-10
Notice Date2018-08-13
PMAP170034
SupplementS
Product CodeOGO
Docket Number18M-3153
Advisory CommitteeOphthalmic
Expedited ReviewNo
Combination Product No
Applicant Address Ivantis, Inc. 38 Discovery, Suite 150 irvine, CA 92618
Summary:Summary of Safety and Effectiveness
Labeling: Labeling Labeling Part 2
Post-Approval Study:Show Report Schedule and Study Progress
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P170034Original Filing
S007 2021-11-03 30-day Notice
S006 2020-12-10 30-day Notice
S005
S004 2019-11-27 Normal 180 Day Track No User Fee
S003 2019-08-27 Normal 180 Day Track No User Fee
S002 2019-07-24 Normal 180 Day Track No User Fee
S001 2018-09-07 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
20867487000138 P170034 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.