|
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 |
Approval Order Statement Approval of the protocol for the post-approval study (PAS) protocol. |