DIMENSION FPSA FLEX REAGENT
FDA premarket approval P020027/S008 · decided 2008-03-14
Approval details
- PMA number
- P020027
- Supplement
- S008
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- DIMENSION FPSA FLEX REAGENT
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2008-03-03
- Decision date
- 2008-03-14
- Days to decision
- 11 days
- Decision code
- APPR
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Newark, DE
- Statement
- APPROVAL FOR THE FOLLOWING CHANGES TO THE PRODUCT INSTRUCTIONS FOR USE: 1) ADD A NEW SECTION TITLED RISK AND SAFETY TO PROVIDE ADDITIONAL SAFETY INFORMATION ABOUT THE PRESERVATIVES PRESENT IN SOME OF THE PRODUCT REAGENTS; 2) ADD INFORMATION UNDER THE SECTION TITLED PRECAUTIONS ON THE PRESENCE OF SODIUM AZIDE, ALONG WITH HAZARD AND DISPOSAL INFORMATION; AND 3) PROVIDE FOR REFERENCE ONLY ADDITIONAL UFU CHANGES BEING IMPLEMENTED CONCURRENTLY WITH THE SAFETY INFORMATION.
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