PMA P980007S023

Device: AXSYM FREE PSA (LN 3C20)
Applicant: Abbott Laboratories
PMA number: P980007
Supplement: S023
Product code: MTG
Decision date: 2011-12-22
Generic name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
Approval order statement: APPROVAL FOR RELOCATION OF BULK SOLUTION PREPARATION TO NEW MANUFACTURING SPACES IN A BUILDING LOCATED WITHIN THE SAME MANUFACTURING FACILITIES.

Current openFDA PMA Record#

Device: AXSYM FREE PSA (LN 3C20)
Applicant: Abbott Laboratories
PMA number: P980007
Supplement: S023
Product code: MTG
Generic name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
Decision date: 2011-12-22
Decision code: APPR
Date received: 2011-11-02
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR RELOCATION OF BULK SOLUTION PREPARATION TO NEW MANUFACTURING SPACES IN A BUILDING LOCATED WITHIN THE SAME MANUFACTURING FACILITIES.