ADVIA CENTAUR CPSA ASSAY
FDA premarket approval P990055/S015 · decided 2016-10-24
Approval details
- PMA number
- P990055
- Supplement
- S015
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ADVIA CENTAUR CPSA ASSAY
- Generic name
- ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2015-05-07
- Decision date
- 2016-10-24
- Days to decision
- 536 days
- Decision code
- APPR
- Product code
- NAF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- Approval for the migration of the ADVIA Centaur cPSA assay to the ADVIA Centaur XPT system
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.