| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | PATHVYSION HER-2 DNA PROBE KIT |
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| Generic Name | SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM |
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| Applicant | ABBOTT MOLECULAR, INC.
1300 EAST TOUHY AVENUE
DES PLAINES, IL 60018 |
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| PMA Number | P980024 |
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| Date Received | 06/16/1998 |
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| Decision Date | 12/11/1998 |
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| Product Code |
MVD |
| Docket Number | 99M-0034 |
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| Notice Date | 01/20/1999 |
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| Advisory Committee |
Pathology |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
Approval for the PathyVysion(TM) HER-2 DNA Probe Kit. The PathyVysion(TM) HER-2 DNA Probe Kit (PathyVysion Kit) is designed to detect amplification ofthe HER-2/neu gene via fluorescence in situ hybridization (FISH) in formalin-fixed paraffin-embedded human breast cancer tissue speciments. Results from the PathVysion Kit are intended for use as an adjuncto to existing clinical and pathologic information currently used as prognostic factors in state II, node-positive breast cancer patients. The PathVysion Kit is further indicated as an aid in predct disease-free and overall survival in patients with stage II, node positive breast cancer treated with adjuvant cyclophosphamide, dosorubicin, and 5-fluorouracil (CAF) chemotherapy. |
| Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011
S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 |
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