PMA P970012S069

Device: KAPPA 400 DR/SR IPG
Applicant: Medtronic, Inc.
PMA number: P970012
Supplement: S069
Product code: NVZ
Decision date: 2010-07-15
Generic name: Pulse generator, permanent, implantable
Approval order statement: APPROVAL FOR AN UPDATE TO COMPONENT PLANTING SPECIFICATION TITLED ¿MATERIAL, PLANTING, AND SURFACE FINISH REQUIREMENTS FOR TERMINALS FOR LASER RIBBON-BONDING (LRB), WIREBONDING (WB), AND PARALLEL GAP WELDING (PGW).¿ (REVISION O).

Current openFDA PMA Record#

Device: KAPPA 400 DR/SR IPG
Applicant: Medtronic, Inc.
PMA number: P970012
Supplement: S069
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2010-07-15
Decision code: APPR
Date received: 2010-05-20
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR AN UPDATE TO COMPONENT PLANTING SPECIFICATION TITLED ¿MATERIAL, PLANTING, AND SURFACE FINISH REQUIREMENTS FOR TERMINALS FOR LASER RIBBON-BONDING (LRB), WIREBONDING (WB), AND PARALLEL GAP WELDING (PGW).¿ (REVISION O).