PMA P990055S007

Device: BAYER ADVIA IMS CPSA ASSAY
Applicant: Siemens Healthcare Diagnostics
PMA number: P990055
Supplement: S007
Product code: NAF
Decision date: 2003-09-02
Classification: Antigen(complexed),prostate Specific,(cpsa)
Generic name: ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
Approval order 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.

Current openFDA PMA Record#

Device: BAYER ADVIA IMS CPSA ASSAY
Applicant: Siemens Healthcare Diagnostics
PMA number: P990055
Supplement: S007
Product code: NAF
Generic name: ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
Decision date: 2003-09-02
Decision code: APPR
Date received: 2003-07-16
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order 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.