WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS

Lenses, Soft Contact, Extended Wear

FDA Premarket Approval P810005

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

DeviceWEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS
Classification NameLenses, Soft Contact, Extended Wear
Generic NameLenses, Soft Contact, Extended Wear
ApplicantCIBA VISION CARE
Date Received1981-02-20
Decision Date1981-09-24
Notice Date1981-11-03
PMAP810005
SupplementS
Product CodeLPM
Docket Number81M-0317
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
P810005Original Filing
S027 1991-05-01 Normal 180 Day Track
S026 1991-04-03 Normal 180 Day Track
S025 1989-11-02 Normal 180 Day Track
S024 1989-08-01 Normal 180 Day Track
S023 1989-07-24 Normal 180 Day Track
S022 1989-07-17 Normal 180 Day Track
S021 1988-05-23 Normal 180 Day Track
S020 1988-01-27 Normal 180 Day Track
S019
S018 1986-05-01
S017 1986-02-20
S016 1986-02-04
S015 1985-07-08
S014 1985-07-02
S013 1985-05-07
S012 1985-01-17
S011 1984-04-26
S010 1984-03-13
S009 1983-12-01
S008
S007 1983-04-15
S006 1982-11-22
S005 1982-11-22
S004 1982-10-04
S003 1982-03-26
S002 1981-10-13
S001 1981-10-13

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