Premarket Approval (PMA)

Note: 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.

• Device: OCUSIL(R) (NEFOCON A) CONTACT LENSES ADD FIN LABS
• Generic Name: Lens, contact (other material) - daily
• Regulation Number: 886.5916
• Applicant: O.S.I. Corp.; 601 Gateway Blvd.,#1050,; South San Francisco, CA 94080
• PMA Number: P840050
• Supplement Number: S048
• Date Received: 01/04/1993
• Decision Date: 04/14/1993
• Reclassified Date: 03/04/1994
• Product Code: HQD
• Advisory Committee: Ophthalmic
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No