WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Premarket Approval P810005 S026

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

DeviceWEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS
Classification NameLenses, Soft Contact, Daily Wear
Generic NameLenses, Soft Contact, Daily Wear
ApplicantCIBA VISION CARE
Date Received1991-04-03
Decision Date1991-08-06
PMAP810005
SupplementS026
Product CodeLPL
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
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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