PMA P910020S015

Device: RELAY/DASH/STRIDE/DART PACING SYSTEMS
Applicant: Boston Scientific
PMA number: P910020
Supplement: S015
Product code: DXY
Decision date: 1996-08-19
Generic name: implantable pacemaker Pulse-generator
Approval order statement: APPROVAL FOR THE USE OF AN ALTERNATE CONDUCTIVE EPOXY AND A PRODUCTION PROCESS CHANGE FOR AUTOMATED APPLICATION OF THIS EPOXY IN THE MANUFACTURE OF IMPLANTABLE PULSE GENERATORS

Current openFDA PMA Record

Device: RELAY/DASH/STRIDE/DART PACING SYSTEMS
Applicant: Boston Scientific
PMA number: P910020
Supplement: S015
Product code: DXY
Generic name: implantable pacemaker Pulse-generator
Decision date: 1996-08-19
Decision code: APPR
Date received: 1996-03-08
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE USE OF AN ALTERNATE CONDUCTIVE EPOXY AND A PRODUCTION PROCESS CHANGE FOR AUTOMATED APPLICATION OF THIS EPOXY IN THE MANUFACTURE OF IMPLANTABLE PULSE GENERATORS