FINISHED METHAFILCON A CONTACT LENSES

Lenses, Soft Contact, Daily Wear

FDA Premarket Approval P890049 S002

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

DeviceFINISHED METHAFILCON A CONTACT LENSES
Classification NameLenses, Soft Contact, Daily Wear
Generic NameLenses, Soft Contact, Daily Wear
ApplicantLOMBART LENSES, LTD.
Date Received1991-06-26
Decision Date1991-07-19
PMAP890049
SupplementS002
Product CodeLPL
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
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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