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 (ETAFILCON A) CONTACT LENSES/CLEAR & VISIBILITY TINTED WITH UV BLOCKER
• Classification Name: lenses, soft contact, extended wear
• Generic Name: contact lenses
• Regulation Number: 886.5925
• Applicant: VISTAKON
• PMA Number: N18033
• Supplement Number: S054
• Date Received: 03/10/2011
• Decision Date: 04/07/2011
• 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: No

Approval Order Statement 
Change in the sampling frequency of an in-process quality audit.