BAYER ADVIA IMS CPSA ASSAY

Antigen(complexed),prostate Specific,(cpsa)

FDA Premarket Approval P990055 S007

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

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.

• Device: BAYER ADVIA IMS CPSA ASSAY
• Classification Name: Antigen(complexed),prostate Specific,(cpsa)
• Generic Name: Antigen(complexed),prostate Specific,(cpsa)
• Applicant: SIEMENS HEALTHCARE DIAGNOSTICS
• Date Received: 2003-07-16
• Decision Date: 2003-09-02
• PMA: P990055
• Supplement: S007
• Product Code: NAF
• Advisory Committee: Immunology
• Supplement Type: Real-time Process
• Supplement Reason: Labeling Change - Indications/instructions/shelf Life/tradename
• Expedited Review: No
• Combination Product: No
• Applicant Address: SIEMENS HEALTHCARE DIAGNOSTICS 333 Coney Street walpole, MA 02032-1516

Supplemental Filings

Supplement Number	Date	Supplement Type
P990055		Original Filing
S024	2022-03-22	30-day Notice
S023	2021-04-01	30-day Notice
S022	2020-07-31	30-day Notice
S021	2020-03-09	30-day Notice
S020	2020-02-21	30-day Notice
S019
S018	2019-02-01	30-day Notice
S017	2018-07-27	Real-time Process
S016	2017-09-29	Normal 180 Day Track
S015	2015-05-07	Normal 180 Day Track
S014	2012-03-26	Normal 180 Day Track No User Fee
S013	2010-08-06	30-day Notice
S012	2009-04-10	Normal 180 Day Track No User Fee
S011	2009-02-06	30-day Notice
S010	2009-03-06	Real-time Process
S009	2006-05-17	Normal 180 Day Track No User Fee
S008	2005-07-22	Real-time Process
S007	2003-07-16	Real-time Process
S006	2003-04-21	Real-time Process
S005	2002-03-28	Normal 180 Day Track
S004	2002-03-06	Normal 180 Day Track
S003	2001-09-20	Normal 180 Day Track
S002	2001-09-20	Normal 180 Day Track
S001	2001-03-27	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
00630414598710	P990055	001
00630414450896	P990055	001
00630414451114	P990055	001
00630414451558	P990055	001
00630414451732	P990055	001
00630414598475	P990055	001
00630414598680	P990055	001
00630414598697	P990055	001
00630414598703	P990055	001
00630414450872	P990055	001