Dimension Vista FPSA Flex reagent cartridge
FDA premarket approval P020027/S034 · decided 2018-12-27
Approval details
- PMA number
- P020027
- Supplement
- S034
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Dimension Vista FPSA Flex reagent cartridge
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2018-09-28
- Decision date
- 2018-12-27
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Newark, DE
- Statement
- Approval for labeling changes describing the impact of endogenous biotin.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.