| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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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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| Supplement Number | S001 |
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| Date Received | 03/30/2001 |
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| Decision Date | 12/31/2001 |
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| Product Code |
MVD |
| Docket Number | 02M-0172 |
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| Notice Date | 04/25/2002 |
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| Advisory Committee |
Pathology |
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| Supplement Type | Panel Track |
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| Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
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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 PATHVYSION HER-2 DNA PROBE KIT. THIS DEVICE IS INDICATED TO DETECT AMPLIFICATION OF THE HER-2/NEU GENE VIA FLUORESCENCE IN SITU HYBRIDIZATION (FISH) IN FORMALIN-FIXED, PARAFFIN-EMBEDDED HUMAN BREAST CANCER TISSUE SPECIMENS. RESULTS FROM THE PATHVYSION KIT ARE INTENDED FOR USE AS AN ADJUNCT TO EXISTING CLINICAL AND PATHOLOGIC INFORMATION CURRENTLY USED AS PROGNOSTIC FACTORS IN STAGE II, NODE-POSITIVE BREAST CANCER PATIENTS. THE PATHVYSION KIT IS FURTHER INDICATED AS AN AID TO PREDICT DISEASE-FREE AND OVERALL SURVIVAL IN PATIENTS WITH STAGE II, NODE POSITIVE BREAST CANCER TREATED WITH ADJUVANT CYCLOPHOSPHAMIDE, DOXORUBICIN, AND 5-FLUOROURACIL (CAF) CHEMOTHERAPY. THE PATHVYSION KIT IS INDICATED AS AN AID IN THE ASSESSMENT OF PATIENTS FOR WHOM HERCEPTIN (TRASTUZUMAB) TREATMENT IS BEING CONSIDERED (SEE HERCEPTIN PACKAGE INSERT). |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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