PMA P970012S008

Device: MEDTRONIC KAPPA 400 SERIES IPG'S
Applicant: Medtronic, Inc.
PMA number: P970012
Supplement: S008
Product code: DXY
Decision date: 1999-03-12
Classification: Implantable Pacemaker Pulse-generator
Generic name: implantable pacemaker Pulse-generator
Approval order statement: Approval for a manufacturing site located at Medtronic Europe S.A., Route de Molliau, Tolochenaz, Switzerland and a final packaging site located at Medtronic B.V., Kerkrade, Wenckebachstraat 10, 6466, Postbus, 1013-6460 BA, Kerkrade, The Netherlands.

Current openFDA PMA Record#

Device: MEDTRONIC KAPPA 400 SERIES IPG'S
Applicant: Medtronic, Inc.
PMA number: P970012
Supplement: S008
Product code: DXY
Generic name: implantable pacemaker Pulse-generator
Decision date: 1999-03-12
Decision code: APPR
Date received: 1998-09-24
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a manufacturing site located at Medtronic Europe S.A., Route de Molliau, Tolochenaz, Switzerland and a final packaging site located at Medtronic B.V., Kerkrade, Wenckebachstraat 10, 6466, Postbus, 1013-6460 BA, Kerkrade, The Netherlands.