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: CUSTOMFLEX (DELTAFILCON A) HYDROPHILIC CONTACT LEN
• Generic Name: Lenses, soft contact, daily wear
• Regulation Number: 886.5925
• Applicant: Wesley Jessen Corp.; 333 E. Howard Ave.; Des Plaines, IL 60018
• PMA Number: N18180
• Supplement Number: S003
• Date Received: 01/19/1981
• Decision Date: 05/11/1981
• Product Code: LPL
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No