Paragon CRT, Paragon CRT 100, Paragon CRT Dual Axis and Paragon RG-4 Rigid Gas Permeable Contact Lenses in Clear and Tin

FDA Premarket Approval P870024 S057

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

Addition of a new laser machine to engrave the lenses.

DeviceParagon CRT, Paragon CRT 100, Paragon CRT Dual Axis and Paragon RG-4 Rigid Gas Permeable Contact Lenses in Clear and Tin
Generic NameLens, Contact (rigid Gas Permeable), Extended Wear
ApplicantPARAGON VISION SCIENCES
Date Received2020-08-05
Decision Date2020-08-31
PMAP870024
SupplementS057
Product CodeMWL 
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address PARAGON VISION SCIENCES 947 East Impala Ave. mesa, AZ 85204

Supplemental Filings

Supplement NumberDateSupplement Type
P870024Original Filing
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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