PATHVYSION HER-2 DNA PROBE KIT
FDA premarket approval P980024/S001 · decided 2001-12-31
Approval details
- PMA number
- P980024
- Supplement
- S001
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PATHVYSION HER-2 DNA PROBE KIT
- Generic name
- SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
- Applicant
- Abbott Molecular, Inc.
- Date received
- 2001-03-30
- Decision date
- 2001-12-31
- Days to decision
- 276 days
- Decision code
- APPR
- Product code
- MVD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Des Plaines, IL
- 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 PRE
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