| Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device. |
| |
| Trade Name | DURASOFT 3 (PHEMFILCON A) UV OPTIFIT TORIC (HYDROPHILLIC) CONTACT LENSES |
|---|
| Classification Name | lenses, soft contact, extended wear |
|---|
| Generic Name | d 3 uv optifit toric d 3 uv spherical |
|---|
| Regulation Number | 886.5925 |
|---|
| Applicant | WESLEY JESSEN CORP. |
|---|
| PMA Number | P830037 |
|---|
| Supplement Number | S041 |
|---|
| Date Received | 07/06/1998 |
|---|
| Decision Date | 05/20/1999 |
|---|
| Product Code | |
| Advisory Committee |
Ophthalmic |
|---|
| Supplement Type | normal 180 day track |
|---|
| Supplement Reason | change design/components/specifications - component |
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product |
No
|
|---|
Approval Order Statement
Approval for the durasoft(r) 3 uv (phemfilcon a) spherical and optifit toric clear, handling tint, colors, and color complements soft (hydrophilic) contact lens (lathe cut) for extended wear to incorporate the pigment carbazole violet as a handling tint at wesley jessen - cidra operation, road 173, km 1. 1, cidra, pr 00739. The pigment will be incorporated as an in-monomer tint by entrapment. |
|
|
