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: TECNIS Symfony Toric IOL
• Generic Name: intraocular lens
• Regulation Number: 886.3600
• Applicant: Johnson & Johnson Surgical Vision, Inc.; 31 Technology Dr., Suite 200; Irvine, CA 92618
• PMA Number: P980040
• Supplement Number: S093
• Date Received: 09/19/2018
• Decision Date: 11/14/2018
• Product Code: HQL
• Advisory Committee: Ophthalmic
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval of revisions to the post-approval study (PAS) protocol.