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: VISTAKON ETAFILCON A BRAND CONTACT LENSES
• Generic Name: Lenses, soft contact, extended wear
• Regulation Number: 886.5925
• Applicant: Vistakon, Johnson & Johnson Vision Products, Inc.; 7500 Centurion Pkwy.; Jacksonville, FL 32256
• PMA Number: N18033
• Supplement Number: S074
• Date Received: 07/15/2014
• Decision Date: 08/14/2014
• Product Code: LPM
• Advisory Committee: Ophthalmic
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
ADDITION OF A QUALITY CONTROL SAMPLING PLAN.