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: EVO/EVO+ VISIAN® Implantable Collamer® Lenses
• Generic Name: Lens, intraocular, phakic
• Applicant: STAAR Surgical Company; 1911 Walker Ave.; Monrovia, CA 91016
• PMA Number: P030016
• Supplement Number: S042
• Date Received: 04/04/2022
• Decision Date: 05/20/2022
• Product Code: MTA
• 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 the protocol for the post-approval study (PAS) protocol.