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 of name change from jsz orthokeratology (oprifilcona) contact lenses for overnight wear to euclid system orthokeratology (oprifilcon a) contact lenses for overnight wear.
| Device | EUCLID SYSTEMS ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENSES FOR OVERNIGHT WEAR |
| Classification Name | Lens, Contact, Orthokeratology, Overnight |
| Generic Name | Lens, Contact, Orthokeratology, Overnight |
| Applicant | Euclid Systems Corporation |
| Date Received | 2016-01-29 |
| Decision Date | 2016-05-26 |
| PMA | P040029 |
| Supplement | S003 |
| Product Code | NUU |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Euclid Systems Corporation 2776 Towerview Rd. herndon, VA 20171 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P040029 | Original Filing | |
| S020 | 2021-06-29 | 30-day Notice |
| S019 | 2021-01-14 | 30-day Notice |
| S018 | ||
| S017 | ||
| S016 | 2020-08-12 | Normal 180 Day Track No User Fee |
| S015 | 2020-05-29 | Normal 180 Day Track |
| S014 | 2020-02-26 | Normal 180 Day Track No User Fee |
| S013 | ||
| S012 | 2020-01-31 | 30-day Notice |
| S011 | ||
| S010 | ||
| S009 | 2019-06-26 | Normal 180 Day Track |
| S008 | 2019-05-08 | Real-time Process |
| S007 | 2019-03-15 | 30-day Notice |
| S006 | ||
| S005 | 2017-08-09 | 30-day Notice |
| S004 | 2016-12-27 | Normal 180 Day Track |
| S003 | 2016-01-29 | Normal 180 Day Track No User Fee |
| S002 | 2015-08-03 | Normal 180 Day Track No User Fee |
| S001 | 2005-08-29 | Normal 180 Day Track No User Fee |