Paragon HDS100 and Fluoroperm 151 Rigid Gas Permeable Contact Lenses in clear and tints

FDA Premarket Approval P870024 S058

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 new manufacturing facility located at paragon vision sciences, inc. , 2120 w guadalupe rd. Gilbert, az 85233

DeviceParagon HDS100 and Fluoroperm 151 Rigid Gas Permeable Contact Lenses in clear and tints
Generic NameLens, Contact (rigid Gas Permeable), Extended Wear
ApplicantCooperVision, Inc.
Date Received2021-01-21
Decision Date2021-04-23
PMAP870024
SupplementS058
Product CodeMWL 
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. 6101 Bollinger Canyon Road, Suite 500 san Ramon, CA 94583

Supplemental Filings

Supplement NumberDateSupplement Type
P870024Original Filing
S058 2021-01-21 Normal 180 Day Track No User Fee
S057 2020-08-05 30-day Notice
S056 2020-08-04 30-day Notice
S055 2020-07-23 30-day Notice
S054 2020-07-22 30-day Notice
S053 2020-03-26 30-day Notice
S052 2019-06-07 30-day Notice
S051
S050
S049 2010-10-25 Normal 180 Day Track No User Fee
S048
S047 2009-06-17 Normal 180 Day Track
S046 2009-03-30 30-day Notice
S045 2004-12-15 30-day Notice
S044 2004-08-31 30-day Notice
S043 2001-10-02 Panel Track
S042 1999-07-12 Normal 180 Day Track
S041 1997-05-12 Normal 180 Day Track
S040 1993-11-12 Normal 180 Day Track
S039 1993-11-12 Normal 180 Day Track
S038 1993-03-24 Normal 180 Day Track
S037 1993-01-28 Normal 180 Day Track
S036 1992-11-18 Normal 180 Day Track
S035 1992-11-12 Normal 180 Day Track
S034 1992-10-20 Normal 180 Day Track
S033 1992-06-18 Normal 180 Day Track
S032 1992-02-20 Normal 180 Day Track
S031 1992-01-27 Normal 180 Day Track
S030 1991-11-12 Normal 180 Day Track
S029 1991-11-06 Normal 180 Day Track
S028
S027 1991-09-19 Normal 180 Day Track
S026 1991-07-31 Normal 180 Day Track
S025 1991-04-18 Normal 180 Day Track
S024 1990-12-06 30-Day Supplement
S023 1990-10-17 Normal 180 Day Track
S022 1990-10-05 Normal 180 Day Track
S021
S020 1990-06-20 30-Day Supplement
S019 1990-05-21 Normal 180 Day Track
S018 1990-04-18 30-Day Supplement
S017 1990-03-14 30-Day Supplement
S016 1990-02-12 Normal 180 Day Track
S015 1989-12-26 Normal 180 Day Track
S014 1989-10-11 Normal 180 Day Track
S013 1989-08-02 Normal 180 Day Track
S012 1989-07-24 Normal 180 Day Track
S011 1989-06-05 Normal 180 Day Track
S010 1989-05-26 Normal 180 Day Track
S009 1989-05-15 Normal 180 Day Track
S008 1989-04-12 Normal 180 Day Track
S007 1989-01-18 Normal 180 Day Track
S006
S005 1988-08-17 Normal 180 Day Track
S004 1988-05-17 Normal 180 Day Track
S003 1988-05-17 Normal 180 Day Track
S002 1988-03-09 Panel Track
S001 1987-11-25 Normal 180 Day Track

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