WEICON (TEFILCON) HYDROPHILIC CONTACT LENSES

Lenses, Soft Contact, Daily Wear

FDA Premarket Approval P800011 S007

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 (TEFILCON) HYDROPHILIC CONTACT LENSES
Classification NameLenses, Soft Contact, Daily Wear
Generic NameLenses, Soft Contact, Daily Wear
ApplicantCIBA VISION CORPORATION
Date Received1985-10-30
Decision Date1985-12-31
PMAP800011
SupplementS007
Product CodeLPL
Advisory CommitteeOphthalmic
Expedited ReviewNo
Combination Product No
Applicant Address CIBA VISION CORPORATION 11460 Johns Creek Pkwy. duluth, GA 30097

Supplemental Filings

Supplement NumberDateSupplement Type
P800011Original Filing
S010 1989-10-24 Normal 180 Day Track
S009 1988-04-14 Normal 180 Day Track
S008 1987-12-30 Normal 180 Day Track
S007 1985-10-30
S006 1984-01-30
S005 1982-05-27
S004 1981-09-14
S003
S002 1980-10-27
S001

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.