OPTACRYL 60 - CLEAR

FDA Premarket Approval P820056 S018

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 - CLEAR
Generic NameLens, Contact (other Material) - Daily
ApplicantPARAGON VISION SCIENCES
Date Received1986-05-06
Decision Date1986-08-04
PMAP820056
SupplementS018
Product CodeHQD 
Advisory CommitteeOphthalmic
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.