OPTACRYL 60 (KOLFOCON A)RGP CONTACT LENS

FDA Premarket Approval P820056 S054

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

DeviceOPTACRYL 60 (KOLFOCON A)RGP CONTACT LENS
Generic NameLens, Contact (other Material) - Daily
ApplicantPARAGON VISION SCIENCES
Date Received1993-03-24
Decision Date1993-04-14
PMAP820056
SupplementS054
Product CodeHQD 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLocation 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
P820056Original Filing
S056 1993-11-12 Normal 180 Day Track
S055 1993-11-12 Normal 180 Day Track
S054 1993-03-24 Normal 180 Day Track
S053 1992-10-20 Normal 180 Day Track
S052 1992-02-20 Normal 180 Day Track
S051 1992-02-11 Normal 180 Day Track
S050 1992-01-27 Normal 180 Day Track
S049 1991-07-31 Normal 180 Day Track
S048 1991-06-14 Normal 180 Day Track
S047 1990-03-14 Normal 180 Day Track
S046 1989-10-11 Normal 180 Day Track
S045 1989-08-07 Normal 180 Day Track
S044 1989-05-23 Normal 180 Day Track
S043 1989-04-20 Normal 180 Day Track
S042 1988-06-21 30-Day Supplement
S041 1988-06-17 30-Day Supplement
S040
S039
S038
S037 1988-04-06 Normal 180 Day Track
S036 1988-04-01 Normal 180 Day Track
S035 1988-01-15 30-Day Supplement
S034
S033
S032 1987-12-29 30-Day Supplement
S031 1987-11-19 30-Day Supplement
S030 1987-08-31 30-Day Supplement
S029 1987-06-09 30-Day Supplement
S028
S027 1987-04-06 30-Day Supplement
S026 1987-01-05 30-Day Supplement
S025 1987-02-02 30-Day Supplement
S024 1987-01-29 Normal 180 Day Track
S023 1986-12-29 Normal 180 Day Track
S022 1986-11-17 30-Day Supplement
S021 1986-09-23 Normal 180 Day Track
S020 1986-09-05 30-Day Supplement
S019
S018 1986-05-06
S017 1986-04-29
S016 1986-04-16
S015
S014 1986-04-01
S013 1986-02-11 Normal 180 Day Track
S012 1985-12-27 Normal 180 Day Track
S011 1985-08-19
S010 1985-08-19
S009 1985-05-02
S008
S007 1984-09-17
S006 1984-05-03
S005 1984-01-20
S004
S003 1983-11-03
S002 1983-08-08
S001 1983-05-11

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