PMA P010012S109

Device: CONTAK CD/EASYTRAK
Applicant: Boston Scientific Corp
PMA number: P010012
Supplement: S109
Product code: LWP
Decision date: 2006-06-28
Classification: Implantable Pulse Generator, Pacemaker (non-crt)
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: APPROVAL FOR THE ADDITION OF IN-LINE LAL TESTING (PYROGENICITY TESTING) TO THE INSPECTION PROCEDURE FOR EACH INCOMING LOT RECEIVED AT GUIDANT FOR THE UNIVERSAL FINISHING WIRE ACCESSORIES.

Current openFDA PMA Record#

Device: CONTAK CD/EASYTRAK
Applicant: Boston Scientific Corp
PMA number: P010012
Supplement: S109
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 2006-06-28
Decision code: APPR
Date received: 2006-03-02
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE ADDITION OF IN-LINE LAL TESTING (PYROGENICITY TESTING) TO THE INSPECTION PROCEDURE FOR EACH INCOMING LOT RECEIVED AT GUIDANT FOR THE UNIVERSAL FINISHING WIRE ACCESSORIES.