PMA P010012S149

Device: CONTAK RENEWAL FAMILY
Applicant: Boston Scientific Corp
PMA number: P010012
Supplement: S149
Product code: LWP
Decision date: 2007-03-29
Classification: Implantable Pulse Generator, Pacemaker (non-crt)
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: APPROVAL FOR THE FOLLOWING CHANGES FOR THE VITALITY AND CONTAK RENEWAL FAMILIES OF DEFIBRILLATORS: 1) REQUIRE THE REED SWITCH COMPONENT SUPPLIER TO EXPOSE 100% OF THE COMPONENTS TO A HIGH MAGNETIC FIELD CONDITION OF MINIMUM OF 30MT, 10 CYCLES WITH 1 SECOND DURATION PRIOR TO SHIPPING TO GUIDANT. 2) APPLY AN ENHANCED QUALITY TEST OF 30MT THROUGH 30 CYCLES AND VERIFY THE REED SWITCH IS OPEN AFTER REMOVING THE DEVICE FROM THE MAGNETIC FIELD, TO ALL DEVICES CURRENTLY HELD UNDER A STOP ACTION NOTICE (SAN).

Current openFDA PMA Record#

Device: CONTAK RENEWAL FAMILY
Applicant: Boston Scientific Corp
PMA number: P010012
Supplement: S149
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 2007-03-29
Decision code: APPR
Date received: 2007-03-13
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE FOLLOWING CHANGES FOR THE VITALITY AND CONTAK RENEWAL FAMILIES OF DEFIBRILLATORS: 1) REQUIRE THE REED SWITCH COMPONENT SUPPLIER TO EXPOSE 100% OF THE COMPONENTS TO A HIGH MAGNETIC FIELD CONDITION OF MINIMUM OF 30MT, 10 CYCLES WITH 1 SECOND DURATION PRIOR TO SHIPPING TO GUIDANT. 2) APPLY AN ENHANCED QUALITY TEST OF 30MT THROUGH 30 CYCLES AND VERIFY THE REED SWITCH IS OPEN AFTER REMOVING THE DEVICE FROM THE MAGNETIC FIELD, TO ALL DEVICES CURRENTLY HELD UNDER A STOP ACTION NOTICE (SAN).