HER2 FISH PHARMADX KIT
FDA premarket approval P040005/S006 · decided 2012-06-08
Approval details
- PMA number
- P040005
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HER2 FISH PHARMADX KIT
- Generic name
- SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- Date received
- 2011-12-05
- Decision date
- 2012-06-08
- Days to decision
- 186 days
- Decision code
- APPR
- Product code
- MVD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Singapore
- Statement
- APPROVAL FOR ADDITION OF PERTUZUMAB IN THE LABELING OF HER2 FISH PHARMDX KIT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HER2 FISH PHARMDX KIT AND ITS INDICATION FOR USE IS: A DIRECT FLUORESCENCE IN SITU HYBRIDIZATION (FISH) ASSAY DESIGNED TOQUANTITATIVELY DETERMINE HER2 GENE AMPLIFICATION IN FORMALIN-FIXED, PARAFFIN-EMBEDDED (FFPE) BREAST CANCER TISSUE SPECIMENS AND FFPE SPECIMENS FROM PATIENTS WITH METASTATIC GASTRIC OR GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA. HER2 FISH PH
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