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: ARMSOF SOFT CONTACT LENSE
• Generic Name: Lenses, soft contact, daily wear
• Regulation Number: 886.5925
• Applicant: Lombart Optical of Virginia, Ltd.; 1215 Boissevain Ave.; Norfolk, VA 23501
• PMA Number: N18018
• Supplement Number: S003
• Date Received: 12/31/1979
• Decision Date: 05/21/1980
• Product Code: LPL
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No