| |
| Trade Name | PARAGON Z CRT (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSES FOR CONTACT LENS CORNEAL REFRACTIVE THERAPY |
|---|
| Classification Name | lens, contact, orthokeratology, overnight |
|---|
| Generic Name | rigid gas permeable,contact lens for orthokeratology |
|---|
| Regulation Number | 886.5916 |
|---|
| Applicant | PARAGON VISION SCIENCES |
|---|
| PMA Number | P050031 |
|---|
| Date Received | 08/26/2005 |
|---|
| Decision Date | 11/16/2006 |
|---|
| Product Code | |
| Docket Number | 06M-0473 |
|---|
| Notice Date | 11/27/2006 |
|---|
| Advisory Committee |
Ophthalmic |
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product |
No
|
|---|
| Information About: |
Labeling, Approval Order, Summary of Safety and Effectiveness |
|---|
Approval Order Statement
Approval for the paragon z crt (tisilfocon a) rigid gas permeable contact lenses for contact lens corneal refractive therapy. The lenses are indicated for use in the reduction of myopic refractive error in non-diseased eyes. The lenses are indicated for overnight wear in the contact lens corneal refractive therapy fitting program for the temporary reduction of myopia up to 6. 00 diopters in eyes with astigmatism up to 1. 75 diopters. The lenses may be disinfected using only a chemical disinfection system. Note: to maintain the contact lens corneal refractive therapy effect of myopia reduction, overnight lens wear must be continued on a prescribed schedule. Failure to do so can affect daily activities (e. G. , night driving), visual fluctuations and changes in intended correction. |
| Approval Order |
Approval Order
|
| Post-Approval Study | Show Report Schedule and Study Progress |
