Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: Tetrafilcon A Soft (Hydrophilic) Extended Wear Contact Lenses
• Generic Name: Lenses, soft contact, extended wear
• Regulation Number: 886.5925
• Applicant: CooperVision, Inc.; 6150 Stoneridge Mall Rd.; Suite 370; Pleasanton, CA 94588
• PMA Number: N17679
• Supplement Number: S037
• Date Received: 09/20/2017
• Decision Date: 10/17/2017
• Product Code: LPM
• Advisory Committee: Ophthalmic
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Installation of a new sterilizer.