| 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 | GENTLE TOUCH UV (NETRAFILCON) SOFT CONTACT LENSES |
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| Classification Name | lenses, soft contact, extended wear |
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| Generic Name | gentle touch uv |
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| Regulation Number | 886.5925 |
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| Applicant | CIBA VISION CORPORATION |
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| PMA Number | P890012 |
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| Supplement Number | S004 |
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| Date Received | 03/25/1999 |
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| Decision Date | 09/12/2000 |
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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 for 1) a change in manufacturing method from lathe-cut to cast-molded; 2) a change in handling tint from vat dyes to d & c green #6; 3) to add an ultraviolet absorber into netrafilcon a lens material; 4) an alternate manufacturing site at wesley jessen pbh, ltd. , southampton, united kingdom; 5) modification to the indicatinos for use including the sentence "gentle touch(tm) uv (netrafilcon a) soft (hydrophilic) contact lenses help to protect against the transmission of harmful uv radiation to the cornea and into the eye"; and 6) modification of the note and warning in labeling. |
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