DIMENSION VISTA FPSA FLEX REAGENT CARTRIDGE
FDA premarket approval P020027/S020 · decided 2013-05-28
Approval details
- PMA number
- P020027
- Supplement
- S020
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- 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
- 2013-05-03
- Decision date
- 2013-05-28
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Newark, DE
- Statement
- CHANGE THE SUPPLIER FOR DEXTRAN T110 FROM SIGMA ADRICH FINE CHEMICALS(SAFC) TO PHARMACOMOS AND TO BRING PHTHALOCYANINE MANUFACTURE IN-HOUSE AT THE SIEMENSHEALTHCARE DIAGNOSTICS, NEWARK, DELAWARE SITE AND THE SCALE-UP OF THE SENSIBEAD CONCENTRATE PRODUCTION FROM 150G PER LOT SIZE TO 300G.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.