IMMULITE Systems PSA, IMMULITE 2000 Systems PSA & IMMULITE Systems Third Generation PSA
FDA premarket approval P930027/S021 · decided 2019-07-11
Approval details
- PMA number
- P930027
- Supplement
- S021
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- IMMULITE Systems PSA, IMMULITE 2000 Systems PSA & IMMULITE Systems Third Generation PSA
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 2019-06-19
- Decision date
- 2019-07-11
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Gwynedd Ll55 4el
- Statement
- Approval for a change to the product quality control (QC) method in order to enhance the safety of IMMULITE® Third Generation PSA High Adjustor (LUPH), IMMULITE® Systems PSA High Adjustor (LPSH) and IMMULITE® 2000 Systems PSA High Adjustor (LPSH)
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