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: N-18 (KOLFOCON A),N-32 (KOLFOCON B) LENS MATERIAL
• Generic Name: Lens, contact (other material) - daily
• Regulation Number: 886.5916
• Applicant: The Lagado Corp.; 2890 S. Tejon St.; Englewood, CO 80110
• PMA Number: P880024
• Supplement Number: S002
• Date Received: 03/05/1993
• Decision Date: 02/24/1994
• Product Code: HQD
• Advisory Committee: Ophthalmic
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Other
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No