| 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 | FRESHLOOK(TM) UV SPHERICAL (PHEMFILCON A) MOLDED SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR |
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| Classification Name | lenses, soft contact, extended wear |
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| Regulation Number | 886.5925 |
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| Applicant | CIBA VISION CORPORATION |
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| PMA Number | P830037 |
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| Supplement Number | S043 |
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| Date Received | 10/10/2000 |
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| Decision Date | 11/09/2000 |
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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 | location change: manufacturer |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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Approval Order Statement
Approval for an alternate manufacturing facility located at wesley jessen pbh limited, southampton, united kingdom. |
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