PMA P990055S012

Device: ADVIA CENTAUR XP CPSA ASSAY ON THE ADVIA CENTAUR XP (WITH VERSION 5.0 SOFTWARE)
Applicant: Siemens Healthcare Diagnostics
PMA number: P990055
Supplement: S012
Product code: NAF
Decision date: 2009-06-10
Classification: Antigen(complexed),prostate Specific,(cpsa)
Generic name: ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
Approval order statement: APPROVAL FOR THE ADDITION OF THE ADVIA CENTAUR XP INSTRUMENT (WITH VERSION 5.0SOFTWARE) TO THE INSTRUMENT(S) USING THE ADVIA CENTAUR CPSA ASSAY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVIA CENTAUR AND ADVIA CENTAUR XP CPSA ASSAY AND ISINDICATED FOR THE MEASUREMENT OF SERUM COMPLEXED PSA IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) AS AN AID IN THE DETECTION OF PROSTATE CANCER IN MEN AGED 50 YEARS AND OLDER. PROSTATE BIOPSY IS REQUIRED FOR THE DIAGNOSIS OF PROSTATE CANCER. THIS ASSAY IS FURTHER INDICATED AS AN AID IN THE MANAGEMENT (MONITORING) OF PATIENTS WITH PROSTATE CANCER.

Current openFDA PMA Record#

Device: ADVIA CENTAUR XP CPSA ASSAY ON THE ADVIA CENTAUR XP (WITH VERSION 5.0 SOFTWARE)
Applicant: Siemens Healthcare Diagnostics
PMA number: P990055
Supplement: S012
Product code: NAF
Generic name: ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
Decision date: 2009-06-10
Decision code: APPR
Date received: 2009-04-10
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE ADDITION OF THE ADVIA CENTAUR XP INSTRUMENT (WITH VERSION 5.0SOFTWARE) TO THE INSTRUMENT(S) USING THE ADVIA CENTAUR CPSA ASSAY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVIA CENTAUR AND ADVIA CENTAUR XP CPSA ASSAY AND ISINDICATED FOR THE MEASUREMENT OF SERUM COMPLEXED PSA IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) AS AN AID IN THE DETECTION OF PROSTATE CANCER IN MEN AGED 50 YEARS AND OLDER. PROSTATE BIOPSY IS REQUIRED FOR THE DIAGNOSIS OF PROSTATE CANCER. THIS ASSAY IS FURTHER INDICATED AS AN AID IN THE MANAGEMENT (MONITORING) OF PATIENTS WITH PROSTATE CANCER.