FINISHED METHAFILCON A CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Premarket Approval P890049 S004

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

• Device: FINISHED METHAFILCON A CONTACT LENSES
• Classification Name: Lenses, Soft Contact, Extended Wear
• Generic Name: Lenses, Soft Contact, Extended Wear
• Applicant: LOMBART LENSES, LTD.
• Date Received: 1998-05-07
• Decision Date: 1998-05-29
• PMA: P890049
• Supplement: S004
• Product Code: LPM
• Advisory Committee: Ophthalmic
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: LOMBART LENSES, LTD. 1215 Boissevain Ave. norfolk, VA 23507

Supplemental Filings

Supplement Number	Date	Supplement Type
P890049		Original 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