BAYER ADVIA IMS CPSA ASSAY
FDA premarket approval P990055/S007 · decided 2003-09-02
Approval details
- PMA number
- P990055
- Supplement
- S007
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- BAYER ADVIA IMS CPSA ASSAY
- Generic name
- ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2003-07-16
- Decision date
- 2003-09-02
- Days to decision
- 48 days
- Decision code
- APPR
- Product code
- NAF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- APPROVAL FOR THE ADDITION OF THE CPSA ASSAY TO THE BAYER ADVIA IMS SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BAYER ADVIA IMS CPSA ASSAY AND IS INDICATED AS AN AID IN THE DETECTION OF PROSTATE CANCER IN MEN AGED 50 YEARS OR OLDER IN CONJUNCTION WITH DIGITAL RECTAL EXAM.
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