PMA P950021S018
- Device
- ADVIA Centaur PSA, ADVIA Centaur CP PSA and Atellica IM PSA
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P950021
- Supplement
- S018
- Product code
- MTG
- Decision date
- 2019-07-25
- Classification
- Test, Prostate Specific Antigen, Free, (noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Approval order statement
- Approval to improve the instructions for use with regards to the High-Dose Hook Effect claim for Prostate Specific Antigen (PSA) with the value obtained using complexed PSA high dose hook in order to enhance the safety of the ADVIA Centaur PSA, ADVIA Centaur CP PSA and Atellica IM PSA.
Current openFDA PMA Record#
- Device
- ADVIA Centaur PSA, ADVIA Centaur CP PSA and Atellica IM PSA
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P950021
- Supplement
- S018
- Product code
- MTG
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Decision date
- 2019-07-25
- Decision code
- APPR
- Date received
- 2019-07-03
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval to improve the instructions for use with regards to the High-Dose Hook Effect claim for Prostate Specific Antigen (PSA) with the value obtained using complexed PSA high dose hook in order to enhance the safety of the ADVIA Centaur PSA, ADVIA Centaur CP PSA and Atellica IM PSA.