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: TETRAFILCON A
• Classification Name: lenses, soft contact, extended wear
• Generic Name: soft hydrophilic contact lenses
• Regulation Number: 886.5925
• Applicant: COOPERVISION, INC.
• PMA Number: N17679
• Supplement Number: S034
• Date Received: 02/23/1999
• Decision Date: 03/17/1999
• Product Code: LPM [ Registered Establishments with LPM ]
• Advisory Committee: Ophthalmic
• Supplement Type: normal 180 day track
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for an alternate tinting process, in-monomer-tinting process.