PMA P940031S019

Device: MERIDEAN, DISCOVERY AND PULSAR PACEMAKERS
Applicant: Boston Scientific
PMA number: P940031
Supplement: S019
Product code: LWP
Decision date: 1999-06-29
Classification: Implantable Pulse Generator, Pacemaker (non-crt)
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: Approval for an alternate manufacturing facility located at Guidant Ireland, Cashel Road, Clonmel Tipperary, Ireland and an alternate sterilization sited located at Isotron Ireland Ltd., Sragh Industrial Estate, Tullamore, Co. Offaly, Ireland.

Current openFDA PMA Record#

Device: MERIDEAN, DISCOVERY AND PULSAR PACEMAKERS
Applicant: Boston Scientific
PMA number: P940031
Supplement: S019
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 1999-06-29
Decision code: APPR
Date received: 1999-06-07
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for an alternate manufacturing facility located at Guidant Ireland, Cashel Road, Clonmel Tipperary, Ireland and an alternate sterilization sited located at Isotron Ireland Ltd., Sragh Industrial Estate, Tullamore, Co. Offaly, Ireland.