FINISHED METHAFILCON A CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Premarket Approval P890049

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

DeviceFINISHED METHAFILCON A CONTACT LENSES
Classification NameLenses, Soft Contact, Extended Wear
Generic NameLenses, Soft Contact, Extended Wear
ApplicantLOMBART LENSES, LTD.
Date Received1989-07-19
Decision Date1989-09-28
PMAP890049
SupplementS
Product CodeLPM
Advisory CommitteeOphthalmic
Expedited ReviewNo
Combination Product No
Applicant Address LOMBART LENSES, LTD. 1215 Boissevain Ave. norfolk, VA 23507

Supplemental Filings

Supplement NumberDateSupplement Type
P890049Original Filing
S004 1998-05-07 30-day Notice
S003 1993-06-08 Normal 180 Day Track
S002 1991-06-26 Normal 180 Day Track
S001 1989-09-14 Normal 180 Day Track

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