PMA P910020S017

Device: MARATHON PACING SYSYTEM
Applicant: Boston Scientific
PMA number: P910020
Supplement: S017
Product code: DXY
Decision date: 1997-02-10
Generic name: implantable pacemaker Pulse-generator
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE MARATHON DR AND SR PULSE GENERATORS, GRAPHICS PROGRAM MODULE MODEL 570-01, AND TO THE RELEASE 2.00 SOFTWARE FOR USE WITH THE RX5000 GRAPHICS PROGRAMMER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES MARATHON Z PULSE GENERATOR MAODELS 294-09Z AND 292-09Z, MOMENTUM DR PULSE GENERATOR MODELS 294-23, 294-23Z, AND 292-23, GRAPHICS PROGRAM MODULE MODEL 570-01, AND RELEASE 2.02 SOFTWARE WITH USE WITH RX5000 GRAPHICS PROGRAMMER, AND IS INDICATED FOR LONG TERM CARDIAC PACING

Current openFDA PMA Record

Device: MARATHON PACING SYSYTEM
Applicant: Boston Scientific
PMA number: P910020
Supplement: S017
Product code: DXY
Generic name: implantable pacemaker Pulse-generator
Decision date: 1997-02-10
Decision code: APPR
Date received: 1996-08-05
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE MARATHON DR AND SR PULSE GENERATORS, GRAPHICS PROGRAM MODULE MODEL 570-01, AND TO THE RELEASE 2.00 SOFTWARE FOR USE WITH THE RX5000 GRAPHICS PROGRAMMER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES MARATHON Z PULSE GENERATOR MAODELS 294-09Z AND 292-09Z, MOMENTUM DR PULSE GENERATOR MODELS 294-23, 294-23Z, AND 292-23, GRAPHICS PROGRAM MODULE MODEL 570-01, AND RELEASE 2.02 SOFTWARE WITH USE WITH RX5000 GRAPHICS PROGRAMMER, AND IS INDICATED FOR LONG TERM CARDIAC PACING