FLEXLENS (HEFILCON A) SOFT CONTACT LENSES

FDA Premarket Approval P900058 S001

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: FLEXLENS (HEFILCON A) SOFT CONTACT LENSES
• Generic Name: Lenses, Soft Contact, Daily Wear
• Applicant: WESTCON CONTACT LENS CO., INC.
• Date Received: 1991-08-27
• Decision Date: 1991-08-29
• PMA: P900058
• Supplement: S001
• Product Code: LPL
• Advisory Committee: Ophthalmic
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Location Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: WESTCON CONTACT LENS CO., INC. 2775 Crossroads Blvd. suite 110 grand Junction, CO 81506

Supplemental Filings

Supplement Number	Date	Supplement Type
P900058		Original Filing
S001	1991-08-27	Normal 180 Day Track