| 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. |
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| Trade Name | DURASOFT 3 (PHEMFILCON A) UV OPTIFIT TORIC AND SPHERICAL CONTACT LENSES |
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| Classification Name | lenses, soft contact, extended wear |
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| Generic Name | contact lenses for extended wear |
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| Regulation Number | 886.5925 |
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| Applicant | WESLEY JESSEN CORP. |
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| PMA Number | P830037 |
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| Supplement Number | S040 |
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| Date Received | 12/18/1996 |
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| Decision Date | 05/15/1997 |
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| Product Code | |
| Advisory Committee |
Ophthalmic |
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| Supplement Type | normal 180 day track |
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| Supplement Reason | process change: manufacturing |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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Approval Order Statement
Approval to add an ultra violet absorber to the clear and litetine lathe cut polymer rods for the subject devices. The devices, as modified, will be marketed under the trade names durasoft(r)3 and durasoft(r)3 uv (phemfilcon a) spherical and optifit(r) toric clear, litetint, colors, and color complements soft (hydrophilic) contact lenses (lathe cut) for extended wear with no change in the currently approved indications for use. |
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