|
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 | S003 |
Date Received | 02/03/2017 |
Decision Date | 04/05/2017 |
Product Code |
LQE |
Advisory Committee |
Ophthalmic |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for revisions to the Postoperative Care Following Inlay Implantation section of Instructions for Use (IFU) and Surgical Planning and Procedures” of the Professional Use Information Brochure for the Raindrop Near Vision Inlay. |