ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses

Lenses, Soft Contact, Extended Wear

FDA Premarket Approval P890023 S039

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

The installation and validation of two new sterilizers at the coopervision, inc. , manufacturing facility in scottsville, new york

Deviceocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses
Classification NameLenses, Soft Contact, Extended Wear
Generic NameLenses, Soft Contact, Extended Wear
ApplicantTHE COOPER COMPANIES
Date Received2019-10-15
Decision Date2019-11-14
PMAP890023
SupplementS039
Product CodeLPM
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address THE COOPER COMPANIES 6150 Stoneridge Mall Road suite 370 pleasanton, CA 94588

Supplemental Filings

Supplement NumberDateSupplement Type
P890023Original Filing
S039 2019-10-15 30-day Notice
S038 2019-08-13 30-day Notice
S037 2019-02-26 30-day Notice
S036 2019-02-08 30-day Notice
S035 2018-08-09 Normal 180 Day Track No User Fee
S034 2018-06-18 Real-time Process
S033 2018-06-15 Real-time Process
S032 2018-04-05 Normal 180 Day Track No User Fee
S031 2018-03-16 135 Review Track For 30-day Notice
S030 2018-01-16 135 Review Track For 30-day Notice
S029 2017-10-24 30-day Notice
S028 2017-08-04 Real-time Process
S027 2017-01-30 30-day Notice
S026 2017-01-08 30-day Notice
S025 2016-04-13 Normal 180 Day Track No User Fee
S024 2015-12-22 30-day Notice
S023 2015-07-02 30-day Notice
S022 2014-09-08 Normal 180 Day Track No User Fee
S021 2013-11-13 135 Review Track For 30-day Notice
S020 2013-11-12 30-day Notice
S019 2013-07-22 30-day Notice
S018 2011-11-01 30-day Notice
S017 2010-04-26 135 Review Track For 30-day Notice
S016 2004-08-18 Real-time Process
S015 2004-07-02 Normal 180 Day Track No User Fee
S014 2003-12-22 Normal 180 Day Track No User Fee
S013 2002-01-18 Normal 180 Day Track
S012
S011 2001-07-20 Normal 180 Day Track
S010
S009 1999-09-17 Normal 180 Day Track
S008 1999-07-29 30-day Notice
S007 1999-04-20 Real-time Process
S006 1996-02-13 Normal 180 Day Track
S005 1995-10-23 Normal 180 Day Track
S004 1995-10-02 Normal 180 Day Track
S003 1995-09-29 Normal 180 Day Track
S002 1993-05-24 Normal 180 Day Track
S001 1990-10-31 Normal 180 Day Track

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