PMA P990055S005

Device: IMMUNO 1 COMPLEXED PSA ASSAY
Applicant: Siemens Healthcare Diagnostics
PMA number: P990055
Supplement: S005
Product code: NAF
Decision date: 2002-09-04
Classification: Antigen(complexed),prostate Specific,(cpsa)
Generic name: ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
Approval order statement: APPROVAL FOR LABELING CHANGES. THE LABELING CHANGES INCLUDE THE REVISION OF LITERATURE CITED IN THE SUMMARY AND EXPLANATION SECTION AND THE ADDITION OF SUMMARY DATA FROM A NEW CLINICAL STUDY. THERE IS NO CHANGE IN THE INDICATION FOR USE.

Current openFDA PMA Record#

Device: IMMUNO 1 COMPLEXED PSA ASSAY
Applicant: Siemens Healthcare Diagnostics
PMA number: P990055
Supplement: S005
Product code: NAF
Generic name: ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
Decision date: 2002-09-04
Decision code: APPR
Date received: 2002-03-28
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR LABELING CHANGES. THE LABELING CHANGES INCLUDE THE REVISION OF LITERATURE CITED IN THE SUMMARY AND EXPLANATION SECTION AND THE ADDITION OF SUMMARY DATA FROM A NEW CLINICAL STUDY. THERE IS NO CHANGE IN THE INDICATION FOR USE.