PMA P980024S001
- Device
- PATHVYSION HER-2 DNA PROBE KIT
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P980024
- Supplement
- S001
- Product code
- MVD
- Decision date
- 2001-12-31
- Classification
- System, Test, Her-2/neu, Nucleic Acid Or Serum
- Generic name
- SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
- 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).
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P980024S001B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- PATHVYSION HER-2 DNA PROBE KIT
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P980024
- Supplement
- S001
- Product code
- MVD
- Generic name
- SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
- Decision date
- 2001-12-31
- Decision code
- APPR
- Date received
- 2001-03-30
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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).