AXSYM TOTAL PSA (LN 3C19)
FDA premarket approval P910007/S032 · decided 2011-12-22
Approval details
- PMA number
- P910007
- Supplement
- S032
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AXSYM TOTAL PSA (LN 3C19)
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Abbott Laboratories
- Date received
- 2011-11-02
- Decision date
- 2011-12-22
- Days to decision
- 50 days
- Decision code
- APPR
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL FOR RELOCATION OF BULK SOLUTION PREPARATION TO NEW MANUFACTURING SPACES IN A BUILDING LOCATED WITHIN THE SAME MANUFACTURING FACILITIES.
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