ADVIA Centaur PSA, ADVIA Centaur CP PSA and Atellica IM PSA
FDA premarket approval P950021/S018 · decided 2019-07-25
Approval details
- PMA number
- P950021
- Supplement
- S018
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ADVIA Centaur PSA, ADVIA Centaur CP PSA and Atellica IM PSA
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2019-07-03
- Decision date
- 2019-07-25
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- East Walpole, MA
- 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.
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