| 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 | THINPREP 2000 SYSTEM |
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| Classification Name | processor, cervical cytology slide, automated |
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| Generic Name | cytology slide preparation device |
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| Applicant | CYTYC CORP. |
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| PMA Number | P950039 |
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| Supplement Number | S012 |
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| Date Received | 08/10/2004 |
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| Decision Date | 08/05/2005 |
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| Product Code | |
| Advisory Committee |
Hematology |
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| Supplement Type | normal 180 day track |
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| Supplement Reason | labeling change - other |
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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 addition to the current labeling, with regard to the evaluation of glandular abnormalities using the thinprep 2000 system. |
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