Hydrus Microstent

FDA Premarket Approval P170034 S006

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

Approval for the reduction in sampling from 100% to aql sampling plans specified by the sponsor.

DeviceHydrus Microstent
Generic NameIntraocular Pressure Lowering Implant
ApplicantIvantis, Inc.
Date Received2020-12-10
Decision Date2021-01-07
PMAP170034
SupplementS006
Product CodeOGO 
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Ivantis, Inc. 38 Discovery, Suite 150 irvine, CA 92618

Supplemental Filings

Supplement NumberDateSupplement Type
P170034Original Filing
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

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