OCUSIL(TM) CONTACT LENS

FDA Premarket Approval P840050

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

DeviceOCUSIL(TM) CONTACT LENS
Generic NameLens, Contact (other Material) - Daily
ApplicantO.S.I. CORP.
Date Received1984-10-09
Decision Date1985-11-20
Notice Date1986-01-02
PMAP840050
SupplementS
Product CodeHQD 
Docket Number85M-0558
Advisory CommitteeOphthalmic
Expedited ReviewNo
Combination Product No
Applicant Address O.S.I. CORP. 601 Gateway Blvd.,#1050, south San Francisco, CA 94080-0000

Supplemental Filings

Supplement NumberDateSupplement Type
P840050Original Filing
S048 1993-01-04 Normal 180 Day Track
S047 1992-08-27 Normal 180 Day Track
S046 1992-06-11 Normal 180 Day Track
S045 1992-05-29 Normal 180 Day Track
S044 1992-02-11 Normal 180 Day Track
S043 1990-03-06 Normal 180 Day Track
S042 1989-09-26 Normal 180 Day Track
S041 1989-02-01 Normal 180 Day Track
S040 1989-01-04 Normal 180 Day Track
S039 1988-10-19 30-Day Supplement
S038 1988-09-13 Normal 180 Day Track
S037 1988-08-02 30-Day Supplement
S036 1988-07-22 30-Day Supplement
S035 1988-06-10 Normal 180 Day Track
S034 1988-04-28 30-Day Supplement
S033 1988-04-05 30-Day Supplement
S032 1988-03-02 Normal 180 Day Track
S031 1988-02-10 Normal 180 Day Track
S030 1988-01-21 30-Day Supplement
S029 1987-12-22 Special (immediate Track)
S028 1987-12-18 30-Day Supplement
S027 1987-12-09 30-Day Supplement
S026 1987-11-23 30-Day Supplement
S025 1987-11-04 30-Day Supplement
S024 1987-10-28 30-Day Supplement
S023 1987-10-28 30-Day Supplement
S022 1987-10-05 30-Day Supplement
S021 1987-09-30 Normal 180 Day Track
S020 1987-09-16 Normal 180 Day Track
S019 1987-08-25 30-Day Supplement
S018 1987-08-19 30-Day Supplement
S017 1987-08-17 30-Day Supplement
S016 1987-07-31 30-Day Supplement
S015 1987-07-21 30-Day Supplement
S014 1987-05-13 30-Day Supplement
S013 1987-05-06 Normal 180 Day Track
S012 1987-04-06 30-Day Supplement
S011 1987-02-04 30-Day Supplement
S010 1986-12-03 30-Day Supplement
S009 1986-10-15 30-Day Supplement
S008 1986-08-27 30-Day Supplement
S007
S006 1986-07-10 Normal 180 Day Track
S005 1986-05-08 Normal 180 Day Track
S004
S003 1986-02-28 Normal 180 Day Track
S002 1985-12-10 30-Day Supplement
S001 1985-11-01 Normal 180 Day Track

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