CustomFlex ArtificialIris

FDA Premarket Approval P170039 S003

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 addition of a second supplier of saline solution used for filling the artificial iris primary packaging

DeviceCustomFlex ArtificialIris
Generic NameArtificial Iris
ApplicantHumanOptics AG
Date Received2019-09-25
Decision Date2020-09-04
PMAP170039
SupplementS003
Product CodeQBT 
Advisory CommitteeOphthalmic
Supplement Type135 Review Track For 30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address HumanOptics AG spardorfer Strasse 150 erlangen 91054

Supplemental Filings

Supplement NumberDateSupplement Type
P170039Original Filing
S003 2019-09-25 135 Review Track For 30-day Notice
S002 2018-07-19 Normal 180 Day Track No User Fee
S001 2018-07-10 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
04049154000029 P170039 000
04049154000012 P170039 000

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