PMA P150034S003

Device: Raindrop Near Vision Inlay
Applicant: Rvo 2.0, Inc. (D.B.A. Optics Medical)
PMA number: P150034
Supplement: S003
Product code: LQE
Decision date: 2017-04-05
Classification: Implant, Corneal, Refractive
Generic name: Implant, corneal, refractive
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.

Current openFDA PMA Record#

Device: Raindrop Near Vision Inlay
Applicant: Rvo 2.0, Inc. (D.B.A. Optics Medical)
PMA number: P150034
Supplement: S003
Product code: LQE
Generic name: Implant, corneal, refractive
Decision date: 2017-04-05
Decision code: APPR
Date received: 2017-02-03
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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.