SOFT CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Premarket Approval N17987 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

DeviceSOFT CONTACT LENS
Classification NameLenses, Soft Contact, Daily Wear
Generic NameLenses, Soft Contact, Daily Wear
ApplicantCIBA VISION CORPORATION
Date Received1988-07-11
Decision Date1988-12-15
PMAN17987
SupplementS018
Product CodeLPL
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
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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