PMA P950021S030

Device: ADVIA Centaur® PSA Immunoassay; Atellica IM Prostate-Specific Antigen (PSA)
Applicant: Siemens Healthcare Diagnostics
PMA number: P950021
Supplement: S030
Product code: MTG
Decision date: 2025-07-16
Classification: Immunology
Generic name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
Approval order statement: Approval for the implementation of a particle size analyzer utilized for the in-process testing of paramagnetic particles.

Current openFDA PMA Record#

Device: ADVIA Centaur® PSA Immunoassay; Atellica IM Prostate-Specific Antigen (PSA)
Applicant: Siemens Healthcare Diagnostics
PMA number: P950021
Supplement: S030
Product code: MTG
Generic name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
Decision date: 2025-07-16
Decision code: OK30
Date received: 2025-06-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the implementation of a particle size analyzer utilized for the in-process testing of paramagnetic particles.