MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear

FDA Premarket Approval P180035 S001

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 a repackaging/relabeling site located at coopervision manufacturing, ltd. , mountpark, unit 1, wide lane, southampton, united kingdom so18 2nq.

DeviceMiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear
Generic NameDaily Wear Soft Contact Lens To Reduce The Progression Of Myopia
ApplicantCooperVision, Inc.
Date Received2019-11-29
Decision Date2020-02-05
PMAP180035
SupplementS001
Product CodeQIT 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address CooperVision, Inc. 5870 Stoneridge Drive suite 1 pleasanton, CA 94588

Supplemental Filings

Supplement NumberDateSupplement Type
P180035Original Filing
S002 2020-01-09 30-day Notice
S001 2019-11-29 Normal 180 Day Track No User Fee

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