PMA P940031S017

Device: MERIDIAN AND DISCOVERY PACEMAKER SYSTEMS
Applicant: Boston Scientific
PMA number: P940031
Supplement: S017
Product code: LWP
Decision date: 1998-08-21
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: Approval for modifications to the DISCOVERY and MERIDIAN pacemakers consisting of changes to the firmware to enhance the performance of existing diagnostic features, and a hardware change to the mixed mode integrated circuit chip to increase the maximum selectable pacing amplitude.

Current openFDA PMA Record#

Device: MERIDIAN AND DISCOVERY PACEMAKER SYSTEMS
Applicant: Boston Scientific
PMA number: P940031
Supplement: S017
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 1998-08-21
Decision code: APPR
Date received: 1998-07-30
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for modifications to the DISCOVERY and MERIDIAN pacemakers consisting of changes to the firmware to enhance the performance of existing diagnostic features, and a hardware change to the mixed mode integrated circuit chip to increase the maximum selectable pacing amplitude.