Raindrop Near Vision Inlay
FDA premarket approval P150034/S005 · decided 2018-03-27
Approval details
- PMA number
- P150034
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Raindrop Near Vision Inlay
- Generic name
- Implant, corneal, refractive
- Applicant
- Rvo 2.0, Inc. (D.B.A. Optics Medical)
- Date received
- 2017-09-29
- Decision date
- 2018-03-27
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- LQE
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Aliso Viejo, CA
- Statement
- Approval to update the device labeling with the 36-month results for the Raindrop® Near Vision Inlay. In addition, the labeling includes minor changes (changing the temperature limit symbol maximum from 55°C to 25°C, removal of translations, updates to the Instructions for Use).
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.