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 for proposed reporting changes to the post-approval study (pas) protocol.
| 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 | 2017-12-21 |
| Decision Date | 2018-02-15 |
| PMA | P150034 |
| Supplement | S007 |
| Product Code | LQE |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Ode/oir |
| 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 |