PMA P150034S006
- Device
- Raindrop Near Vision Inlay
- Applicant
- Rvo 2.0, Inc. (D.B.A. Optics Medical)
- PMA number
- P150034
- Supplement
- S006
- Product code
- LQE
- Decision date
- 2018-01-12
- Classification
- Implant, Corneal, Refractive
- Generic name
- Implant, corneal, refractive
- Approval order statement
- Alternative shortened purification process 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
- S006
- Product code
- LQE
- Generic name
- Implant, corneal, refractive
- Decision date
- 2018-01-12
- Decision code
- OK30
- Date received
- 2017-12-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternative shortened purification process for the Raindrop® Near Vision Inlay.