PMA P990055

Device: ADVIA Centaur® Complexed PSA (cPSA) Immunoassay; Atellica IM Complexed Prostate-Specific Antigen (cPSA)
Applicant: Siemens Healthcare Diagnostics
PMA number: P990055
Supplement: S024
Product code: NAF
Decision date: 2025-07-16
Generic name: ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
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® Complexed PSA (cPSA) Immunoassay; Atellica IM Complexed Prostate-Specific Antigen (cPSA)
Applicant: Siemens Healthcare Diagnostics
PMA number: P990055
Supplement: S029
Product code: NAF
Generic name: ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
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.