PMA P830045S058

Device: APSU PROGRAMMER, APSU SOFTWARE, BASE STATION
Applicant: St. Jude Medical, Inc.
PMA number: P830045
Supplement: S058
Product code: LWP
Decision date: 1998-07-14
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: Approval for software modifications to the APS III Programmer Software Model 3302 Revision B (Paragon Version 1.02) resulting in APS III Programmer software Model 3302 Revision C (Paragon Version 1.03).

Current openFDA PMA Record

Device: APSU PROGRAMMER, APSU SOFTWARE, BASE STATION
Applicant: St. Jude Medical, Inc.
PMA number: P830045
Supplement: S058
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 1998-07-14
Decision code: APPR
Date received: 1998-06-30
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for software modifications to the APS III Programmer Software Model 3302 Revision B (Paragon Version 1.02) resulting in APS III Programmer software Model 3302 Revision C (Paragon Version 1.03).