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

• Device: CustomFlex ArtificialIris
• Generic Name: Artificial Iris
• Applicant: HumanOptics AG
• Date Received: 2019-09-25
• Decision Date: 2020-09-04
• PMA: P170039
• Supplement: S003
• Product Code: QBT
• Advisory Committee: Ophthalmic
• Supplement Type: 135 Review Track For 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: HumanOptics AG spardorfer Strasse 150 erlangen 91054

Supplemental Filings

Supplement Number	Date	Supplement Type
P170039		Original 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 ID	PMA	Supp
04049154000029	P170039	000
04049154000012	P170039	000