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: METHAFILCON A
• Classification Name: lenses, soft contact, extended wear
• Generic Name: soft hydrophilic contact lenses
• Regulation Number: 886.5925
• Applicant: COOPERVISION, INC.
• PMA Number: P850079
• Supplement Number: S036
• Date Received: 03/06/2000
• Decision Date: 03/23/2000
• 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 
Introduction of an alternate manufacturing process for the extended wear contact lens.