PMA P880086S049

Device: POLARITY PULSE GENERATOR MODELS 209K AND 2091M/S
Applicant: ABBOTT MEDICAL
PMA number: P880086
Supplement: S049
Product code: DXY
Decision date: 1998-07-14
Classification: Implantable Pacemaker Pulse-generator
Generic name: implantable pacemaker Pulse-generator
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: POLARITY PULSE GENERATOR MODELS 209K AND 2091M/S
Applicant: ABBOTT MEDICAL
PMA number: P880086
Supplement: S049
Product code: DXY
Generic name: implantable pacemaker Pulse-generator
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).