ABBOTT IMX TOTAL PSA
FDA premarket approval P910007/S009 · decided 2004-02-02
Approval details
- PMA number
- P910007
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ABBOTT IMX TOTAL PSA
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Applicant
- Abbott Laboratories
- Date received
- 2003-01-31
- Decision date
- 2004-02-02
- Days to decision
- 367 days
- Decision code
- APPR
- Product code
- LTJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL FOR THE ABBOTT IMX TOTAL PSA ASSAY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ABBOTT IMX TOTAL PSA ASSAY AND IS INDICATED AS AN AID IN THE DETECTION OF PROSTATE CANCER WHEN USED IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) IN MEN AGED 50 YEARS OR OLDER. PROSTATIC BIOPSY IS REQUIRED FOR THE DIAGNOSIS OF CANCER.
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