FDA.reportPublic FDA data

PMA P990055S021

Device
Atellica IM Complexed PSA (cPSA) Assay
Applicant
Siemens Healthcare Diagnostics
PMA number
P990055
Supplement
S021
Product code
NAF
Decision date
2020-04-03
Generic name
ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
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 Complexed PSA (cPSA) Assay
Applicant
Siemens Healthcare Diagnostics
PMA number
P990055
Supplement
S021
Product code
NAF
Generic name
ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
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).