PMA P910020S012

Device: UNITY MODEL 292-06 SINGLE PASS PULSE GENERATOR
Applicant: Boston Scientific
PMA number: P910020
Supplement: S012
Product code: DXY
Decision date: 1996-07-31
Generic name: implantable pacemaker Pulse-generator
Approval order statement: APPROVAL FOR THE UNITY MODEL 292-07 SINGLE PASS (VDDR) PULSE GENERATOR WITH UNIPASS LEADS MODELS 425-02, 425-04 AND 425-06 AND MODEL 531-60 GRAPHICS PROGRAM MODULE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME UNITY

Current openFDA PMA Record

Device: UNITY MODEL 292-06 SINGLE PASS PULSE GENERATOR
Applicant: Boston Scientific
PMA number: P910020
Supplement: S012
Product code: DXY
Generic name: implantable pacemaker Pulse-generator
Decision date: 1996-07-31
Decision code: APPR
Date received: 1995-09-11
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE UNITY MODEL 292-07 SINGLE PASS (VDDR) PULSE GENERATOR WITH UNIPASS LEADS MODELS 425-02, 425-04 AND 425-06 AND MODEL 531-60 GRAPHICS PROGRAM MODULE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME UNITY