This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
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).
| Device | Raindrop Near Vision Inlay |
| Classification Name | Implant, Corneal, Refractive |
| 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 |
| PMA | P150034 |
| Supplement | S005 |
| Product Code | LQE |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | RVO 2.0, Inc. (d.b.a. Optics Medical) 65 Enterprise Suite 455 aliso Viejo, CA 92656 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P150034 | Original Filing | |
| S009 | 2021-12-09 | Normal 180 Day Track No User Fee |
| S008 | 2019-08-19 | Normal 180 Day Track No User Fee |
| S007 | 2017-12-21 | Normal 180 Day Track No User Fee |
| S006 | 2017-12-18 | 30-day Notice |
| S005 | 2017-09-29 | Normal 180 Day Track |
| S004 | 2017-09-29 | 30-day Notice |
| S003 | 2017-02-03 | Special (immediate Track) |
| S002 | 2016-07-29 | Normal 180 Day Track No User Fee |
| S001 | 2016-07-29 | Normal 180 Day Track No User Fee |