|
Device | Raindrop® Near Vision Inlay |
Generic Name | Implant, corneal, refractive |
Applicant | RVO 2.0, Inc. (d.b.a. Optics Medical) 65 Enterprise Suite 455 Aliso Viejo, CA 92656 |
PMA Number | P150034 |
Supplement Number | S009 |
Date Received | 12/09/2021 |
Decision Date | 01/04/2022 |
Product Code |
LQE |
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 to place the study on hold for the post-approval study (PAS) protocol. |