- Device
- AXSYM TOTAL PSA
- Applicant
- Abbott Laboratories
- PMA number
- P910007
- Supplement
- S025
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2011-06-10
- Decision code
- APPR
- Date received
- 2011-01-31
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT IRELAND DIAGNOSTICS DIVISION IN SLIGO, IRELAND.