PMA P910007S022

Device: AXSYM TOTAL PSA
Applicant: Abbott Laboratories
PMA number: P910007
Supplement: S022
Product code: MTF
Decision date: 2011-05-20
Generic name: Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT LABORATORIES IN NORTH CHICAGO, ILLINOIS.

Current openFDA PMA Record#

Device: AXSYM TOTAL PSA
Applicant: Abbott Laboratories
PMA number: P910007
Supplement: S022
Product code: MTF
Generic name: Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Decision date: 2011-05-20
Decision code: APPR
Date received: 2010-11-01
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 LABORATORIES IN NORTH CHICAGO, ILLINOIS.