CSI CONTACT LENS

Lenses, Soft Contact, Extended Wear

FDA Premarket Approval N17987

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

DeviceCSI CONTACT LENS
Classification NameLenses, Soft Contact, Extended Wear
Generic NameLenses, Soft Contact, Extended Wear
ApplicantCIBA VISION CORPORATION
Date Received1980-01-09
Decision Date1980-09-19
PMAN17987
SupplementS
Product CodeLPM
Advisory CommitteeOphthalmic
Expedited ReviewNo
Combination Product No
Applicant Address CIBA VISION CORPORATION 11460 Johns Creek Parkway duluth, GA 30097

Supplemental Filings

Supplement NumberDateSupplement Type
N17987Original Filing
S028 1999-10-27 Normal 180 Day Track
S027 1999-09-01 Normal 180 Day Track
S026 1999-07-28 Normal 180 Day Track
S025
S024 1992-08-24 Normal 180 Day Track
S023
S022
S021 1989-08-23 Normal 180 Day Track
S020 1989-07-24 Normal 180 Day Track
S019 1988-12-23 Normal 180 Day Track
S018 1988-07-11 Normal 180 Day Track
S017 1988-05-13 Normal 180 Day Track
S016 1987-12-15 Normal 180 Day Track
S015 1987-06-02 30-Day Supplement
S014 1987-05-26 Normal 180 Day Track
S013 1985-12-10
S012 1985-04-02
S011 1984-09-24
S010 1984-01-25
S009 1983-07-28
S008 1983-03-30
S007 1983-01-17
S006 1981-11-12
S005
S004 1980-11-17
S003
S002 1979-11-15
S001 1979-09-14

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