Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: VISTAKON (SENOFILCON A) CONTACT LENSES/CLEAR/VISIBILITY TINTED WITH UV BLOCKER
• Classification Name: lenses, soft contact, extended wear
• Regulation Number: 886.5925
• Applicant: VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR
• PMA Number: P040045
• Supplement Number: S015
• Date Received: 08/25/2010
• Decision Date: 09/24/2010
• Product Code: LPM [ Registered Establishments with LPM ]
• Advisory Committee: Ophthalmic
• Supplement Type: 30-day notice
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: Yes

Approval Order Statement 
Change to the oxygen permeability test method tm-0534.