OCUSIL(TM) CONTACT LENS

FDA Premarket Approval P840050 S025

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

DeviceOCUSIL(TM) CONTACT LENS
Generic NameLens, Contact (other Material) - Daily
ApplicantO.S.I. CORP.
Date Received1987-11-04
Decision Date1987-12-01
PMAP840050
SupplementS025
Product CodeHQD 
Advisory CommitteeOphthalmic
Supplement Type30-Day Supplement
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
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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