PMA P010012S074

Device: EASYTRAK 3 IS-1 AND LV-1 HEART FAILURE LEADS
Applicant: Boston Scientific Corp
PMA number: P010012
Supplement: S074
Product code: LWP
Decision date: 2006-02-16
Classification: Implantable Pulse Generator, Pacemaker (non-crt)
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: APPROVAL FOR THE ADDITION OF A CLARIFICATION AND INSPECTION STEP TO THE PROXIMAL ELECTRODE MANUFACTURING ASSEMBLY PROCESS FOR EASYTRAK LEADS.

Current openFDA PMA Record#

Device: EASYTRAK 3 IS-1 AND LV-1 HEART FAILURE LEADS
Applicant: Boston Scientific Corp
PMA number: P010012
Supplement: S074
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 2006-02-16
Decision code: APPR
Date received: 2005-09-02
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE ADDITION OF A CLARIFICATION AND INSPECTION STEP TO THE PROXIMAL ELECTRODE MANUFACTURING ASSEMBLY PROCESS FOR EASYTRAK LEADS.