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: FOCUS(R) & NEWVUES(R) SOFT CONTACT LENSES
• Classification Name: lenses, soft contact, extended wear
• Generic Name: soft contact lenses
• Regulation Number: 886.5925
• Applicant: CIBA VISION CORPORATION
• PMA Number: P820021
• Supplement Number: S029
• Date Received: 05/10/1996
• Decision Date: 09/25/1996
• Product Code: LPM [ Registered Establishments with LPM ]
• Advisory Committee: Ophthalmic
• Supplement Type: normal 180 day track
• Supplement Reason: labeling change - instructions
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for revised labeling (i. E. , package insert, practitioner fitting guide, and separate patient information booklets for lenses prescribed for frequent replacement wear (focus, focus toric, and newvues (vifilcon a) soft (hydrophilic) contact lenses) and disposable wear (newvues (vifilcon a) soft (hydrophilic) contact lenses). Revisions included (1)merging planned replacement and disposable wearing schedules for the lensese into one package insert and directing the package isert to the eyecare practitioner, (2)writing separate patient instructions for lenses prescribed for disposable and frequent replacement wear, (3)updating the professional fitting guide for consistency with other labeling items, and (4)bringing the labeling up-to-date with fda's current recommendations in an effort to increase consumer comprehension and compliance. The revisions do no result in changes in the devices themselves or the indications for use of the devices.