PMA P910020S020

Device: MOMENTUM PACERS
Applicant: Boston Scientific
PMA number: P910020
Supplement: S020
Product code: DXY
Decision date: 1998-01-30
Generic name: implantable pacemaker Pulse-generator
Approval order statement: Approval for the Edgeband Design on the Marathon SR Model 292-09, Relay Model 293-03, Marathon DR Model 293-09, Marathon DR Model 294-09, and Mementum DR Model 294-23. The devices, as modified, will be marketed under the trade name Edgeband pacemakers, with the following models: Marathon SR Model 292-09E, Relay Model 293-03E, Marathone DR Model 293-09E, Marathon DR Model 294-09E, and Momentum DR Model 294-23E. The supplement also requested approval for the use of an alternate packaging of Polyethylene Terephthalate Glycol (PETG) for all Edgeband and all Side-Lock(TM) pulse generator models.

Current openFDA PMA Record

Device: MOMENTUM PACERS
Applicant: Boston Scientific
PMA number: P910020
Supplement: S020
Product code: DXY
Generic name: implantable pacemaker Pulse-generator
Decision date: 1998-01-30
Decision code: APPR
Date received: 1998-01-08
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the Edgeband Design on the Marathon SR Model 292-09, Relay Model 293-03, Marathon DR Model 293-09, Marathon DR Model 294-09, and Mementum DR Model 294-23. The devices, as modified, will be marketed under the trade name Edgeband pacemakers, with the following models: Marathon SR Model 292-09E, Relay Model 293-03E, Marathone DR Model 293-09E, Marathon DR Model 294-09E, and Momentum DR Model 294-23E. The supplement also requested approval for the use of an alternate packaging of Polyethylene Terephthalate Glycol (PETG) for all Edgeband and all Side-Lock(TM) pulse generator models.