MiSight 1 day (omafilcon A)

FDA Premarket Approval P180035 S010

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

DeviceMiSight 1 day (omafilcon A)
Generic NameDaily Wear Soft Contact Lens To Reduce The Progression Of Myopia
ApplicantCooperVision, Inc.5870 Stoneridge Drivesuite 1pleasanton, CA 94588 PMA NumberP180035 Supplement NumberS010 Date Received08/17/2022 Decision Date09/15/2022 Product Code QIT  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-08-17
Decision Date2022-09-15
PMAP180035
SupplementS010
Product CodeQIT 
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressCooperVision, Inc.
5870 Stoneridge Drive
suite 1
pleasanton, CA 94588 PMA NumberP180035 Supplement NumberS010 Date Received08/17/2022 Decision Date09/15/2022 Product Code QIT  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
the Manufacture Of MiSight 1 Day Product On Dry Line HE And Wet Line HVE At The CooperVision Warrior Close Manufacturing Facility In Chandlers Ford, Eastleigh, UK

Supplemental Filings

Supplement NumberDateSupplement Type
P180035Original Filing
S011 2022-08-23 30-day Notice
S010 2022-08-17 30-day Notice
S009 2021-12-29 30-day Notice
S008 2021-03-08 30-day Notice
S007 2021-03-05 30-day Notice
S006 2020-04-17 Real-time Process
S005 2020-02-13 30-day Notice
S004
S003
S002 2020-01-09 30-day Notice
S001 2019-11-29 Normal 180 Day Track No User Fee

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