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 place the study on hold for the post-approval study (pas) referenced above. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for p150034.
| Device | Raindrop® Near Vision Inlay |
| Generic Name | Implant, Corneal, Refractive |
| Applicant | RVO 2.0, Inc. (d.b.a. Optics Medical) |
| Date Received | 2021-12-09 |
| Decision Date | 2022-01-04 |
| PMA | P150034 |
| Supplement | S009 |
| Product Code | LQE |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol |
| 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 |