FDA.reportPublic FDA data

PMA P950021S021

Device
Atellica IM Prostate-Specific Antigen (PSA) Assay
Applicant
Siemens Healthcare Diagnostics
PMA number
P950021
Supplement
S021
Product code
MTF
Decision date
2020-04-03
Generic name
Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Approval order statement
Modification to the manufacturing process to add a second manufacturing site for optional sample handling subsystem (Atellica Direct Load) for the Atellica IM Analyzer (Immunoassay Module).

Current openFDA PMA Record#

Device
Atellica IM Prostate-Specific Antigen (PSA) Assay
Applicant
Siemens Healthcare Diagnostics
PMA number
P950021
Supplement
S021
Product code
MTF
Generic name
Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Decision date
2020-04-03
Decision code
OK30
Date received
2020-03-09
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Modification to the manufacturing process to add a second manufacturing site for optional sample handling subsystem (Atellica Direct Load) for the Atellica IM Analyzer (Immunoassay Module).