PMA P910020S014

Device: RELAY/DASH/STRIDE/DART PACING SYSTEMS
Applicant: Boston Scientific
PMA number: P910020
Supplement: S014
Product code: DXY
Decision date: 1996-03-03
Generic name: implantable pacemaker Pulse-generator
Approval order statement: APPROVAL FOR THE INTRODUCTION OF LABELING ADDRESSING COMPATIBILITY OF PACEMAKERS WITH CELLULAR TELEPHONES. SPECIFICALLY THE FOLLOWING MODELS ARE AFFECTED:RELAY:293-03/294-03/294-03R -- DASH:291-03/292-03/292-03R -- STRIDE:294-05 -- DART:292-05 -- UNITY-C:292-06

Current openFDA PMA Record

Device: RELAY/DASH/STRIDE/DART PACING SYSTEMS
Applicant: Boston Scientific
PMA number: P910020
Supplement: S014
Product code: DXY
Generic name: implantable pacemaker Pulse-generator
Decision date: 1996-03-03
Decision code: APPR
Date received: 1996-02-01
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE INTRODUCTION OF LABELING ADDRESSING COMPATIBILITY OF PACEMAKERS WITH CELLULAR TELEPHONES. SPECIFICALLY THE FOLLOWING MODELS ARE AFFECTED:RELAY:293-03/294-03/294-03R -- DASH:291-03/292-03/292-03R -- STRIDE:294-05 -- DART:292-05 -- UNITY-C:292-06