PMA P150034S009
- Device
- Raindrop® Near Vision Inlay
- Applicant
- Rvo 2.0, Inc. (D.B.A. Optics Medical)
- PMA number
- P150034
- Supplement
- S009
- Product code
- LQE
- Decision date
- 2022-01-04
- Generic name
- Implant, corneal, refractive
- Approval order statement
- Approval to place the study on hold for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- Raindrop® Near Vision Inlay
- Applicant
- Rvo 2.0, Inc. (D.B.A. Optics Medical)
- PMA number
- P150034
- Supplement
- S009
- Product code
- LQE
- Generic name
- Implant, corneal, refractive
- Decision date
- 2022-01-04
- Decision code
- APPR
- Date received
- 2021-12-09
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval to place the study on hold for the post-approval study (PAS) protocol.