| 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 | CEEON INTRAOCULAR LENSES |
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| Classification Name | lens, multifocal intraocular |
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| Generic Name | intraocular lens |
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| Regulation Number | 886.3600 |
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| Applicant | ADVANCED MEDICAL OPTICS, INC. |
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| PMA Number | P960028 |
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| Supplement Number | S016 |
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| Date Received | 10/10/2006 |
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| Decision Date | 10/18/2006 |
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| Product Code | |
| Advisory Committee |
Ophthalmic |
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| Supplement Type | 30-day notice |
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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
Change to clean room specifications to improve efficiency, environmental specifications and modifications, and continuous product flow. |
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