Approval for a labeling update to the package insert and patient information booklet to include the results from a section 522 postmarket surveillance study (pas).
| Device | PARAGON CRT LENS |
| Classification Name | Lens, Contact (rigid Gas Permeable), Extended Wear |
| Generic Name | Lens, Contact (rigid Gas Permeable), Extended Wear |
| Applicant | PARAGON VISION SCIENCES |
| Date Received | 2010-10-25 |
| Decision Date | 2014-07-28 |
| PMA | P050031 |
| Supplement | S001 |
| Product Code | MWL |
| 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 | PARAGON VISION SCIENCES 947 East Impala Ave. mesa, AZ 85204 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P050031 | | Original Filing |
| S009 |
2022-04-15 |
30-day Notice |
| S008 | | |
| S007 |
2020-08-05 |
30-day Notice |
| S006 |
2020-08-04 |
30-day Notice |
| S005 |
2019-03-13 |
Normal 180 Day Track No User Fee |
| S004 | | |
| S003 |
2019-02-04 |
Real-time Process |
| S002 | | |
| S001 |
2010-10-25 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices