SIGNATURE CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Premarket Approval P890012

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

DeviceSIGNATURE CONTACT LENS
Classification NameLenses, Soft Contact, Daily Wear
Generic NameLenses, Soft Contact, Daily Wear
ApplicantCIBA VISION CORPORATION
Date Received1989-03-03
Decision Date1989-09-15
Notice Date1989-11-27
PMAP890012
SupplementS
Product CodeLPL
Docket Number89M-0463
Advisory CommitteeOphthalmic
Expedited ReviewNo
Combination Product No
Applicant Address CIBA VISION CORPORATION 11460 Johns Creek Parkway duluth, GA 30097

Supplemental Filings

Supplement NumberDateSupplement Type
P890012Original Filing
S005 2000-02-28 Normal 180 Day Track
S004 1999-03-25 Normal 180 Day Track
S003 1994-10-06 30-Day Supplement
S002 1990-12-28 Normal 180 Day Track
S001 1989-09-25 Normal 180 Day Track

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