PMA P150034S008
- Device
- Raindrop Near Vision Inlay
- Applicant
- Rvo 2.0, Inc. (D.B.A. Optics Medical)
- PMA number
- P150034
- Supplement
- S008
- Product code
- LQE
- Decision date
- 2019-10-09
- Classification
- Implant, Corneal, Refractive
- Generic name
- Implant, corneal, refractive
- Approval order statement
- Approval to temporarily suspend the New Enrollment PAS due to not distributing or marketing of the device.
Current openFDA PMA Record#
- Device
- Raindrop Near Vision Inlay
- Applicant
- Rvo 2.0, Inc. (D.B.A. Optics Medical)
- PMA number
- P150034
- Supplement
- S008
- Product code
- LQE
- Generic name
- Implant, corneal, refractive
- Decision date
- 2019-10-09
- Decision code
- APPR
- Date received
- 2019-08-19
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval to temporarily suspend the New Enrollment PAS due to not distributing or marketing of the device.