CIBATINT(TM) TINTING PROCESS

FDA Premarket Approval P820086

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

DeviceCIBATINT(TM) TINTING PROCESS
Generic NameLenses, Soft Contact, Extended Wear
ApplicantCIBA VISION CARE
Date Received1982-12-20
Decision Date1984-02-08
Notice Date1984-04-10
PMAP820086
SupplementS
Product CodeLPM 
Docket Number84M-0091
Advisory CommitteeOphthalmic
Expedited ReviewNo
Combination Product No
Applicant Address CIBA VISION CARE 11460 Johns Creek Pkwy. duluth, GA 30136-1518

Supplemental Filings

Supplement NumberDateSupplement Type
P820086Original Filing
S012 1989-08-01 Normal 180 Day Track
S011 1989-07-27 Normal 180 Day Track
S010 1989-07-24 Normal 180 Day Track
S009
S008 1988-05-23 Normal 180 Day Track
S007
S006 1986-02-20
S005 1985-05-10
S004 1985-02-07
S003 1985-01-17
S002
S001 1984-03-09

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