FLUOROCON TM-60

Lens, Contact (rigid Gas Permeable), Extended Wear

FDA Premarket Approval P890020

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

DeviceFLUOROCON TM-60
Classification NameLens, Contact (rigid Gas Permeable), Extended Wear
Generic NameLens, Contact (rigid Gas Permeable), Extended Wear
ApplicantCIBA VISION CORPORATION
Date Received1989-03-20
Decision Date1989-06-23
Notice Date1989-08-24
PMAP890020
SupplementS
Product CodeMWL
Docket Number89M-0313
Advisory CommitteeOphthalmic
Expedited ReviewNo
Combination Product No
Applicant Address CIBA VISION CORPORATION 11460 Johns Creek Parkway duluth, GA 30097

Supplemental Filings

Supplement NumberDateSupplement Type
P890020Original Filing
S002 1990-07-16 Normal 180 Day Track
S001 1989-09-29 Normal 180 Day Track

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