ABBOTT ARCHITECT TOTAL PSA
FDA premarket approval P910007/S007 · decided 2004-02-02
Approval details
- PMA number
- P910007
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ABBOTT ARCHITECT TOTAL PSA
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Abbott Laboratories
- Date received
- 2001-12-05
- Decision date
- 2004-02-02
- Days to decision
- 789 days
- Decision code
- APPR
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL FOR THE ABBOTT ARCHITECT TOTAL PSA ASSAY. THE ARCHITECT TOTAL PSA ASSAY IS INDICATED: 1) AS AN AID IN THE DETECTION OF PROSTATE CANCER WHEN USED IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) IN MEN 50 YEARS OR OLDER. PROSTATE BIOPSY IS REQUIRED FOR DIAGNOSIS OF CANCER. 2) AS AN ADJUNCTIVE TEST TO AID IN THE MANAGEMENT OF PROSTATE CANCER PATIENTS.
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