ABBOTT AXSYM FREE PSA ASSAY
FDA premarket approval P980007/S005 · decided 2004-09-10
Approval details
- PMA number
- P980007
- Supplement
- S005
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ABBOTT AXSYM FREE PSA ASSAY
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Applicant
- Abbott Laboratories
- Date received
- 2004-08-05
- Decision date
- 2004-09-10
- Days to decision
- 36 days
- Decision code
- APPR
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL FOR THE ADDITION OF FLOMAX TO THE ANALYTICAL SPECIFICITY SECTION OF THE PACKAGE INSERT AND MINOR LABELING CHANGES TO THE ABBOTT AXSYM FREE PSA ASSAY FOR THE PURPOSE OF CLARIFICATION, UPDATES AND CONFORMATION TO REQUIREMENTS OF THE EUROPEAN COMMUNITY DIRECTIVES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE SAME TRADE NAME AXSYM FREE PSA ASSAY AND IS INDICATED AS FOLLOWS: THE AXSYM FREE PSA ASSAY IS A MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) FOR THE QUANTITATIVE MEASUREMENT OF FREE
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