AXSYM FREE PSA
FDA premarket approval P980007/S016 · decided 2011-06-10
Approval details
- PMA number
- P980007
- Supplement
- S016
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AXSYM FREE PSA
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Applicant
- Abbott Laboratories
- Date received
- 2011-01-31
- Decision date
- 2011-06-10
- Days to decision
- 130 days
- Decision code
- APPR
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT IRELAND DIAGNOSTICS DIVISION IN SLIGO, IRELAND.
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