PMA P980016S951

Device: Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2DL DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI IC
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P980016
Supplement: S951
Product code: LWS
Decision date: 2026-04-30
Classification: Cardiovascular
Generic name: Implantable cardioverter defibrillator (non-CRT)
Approval order statement: Approval for updates to the manufacturing acceptance conditions for plated through holes in hybrid subassemblies incorporated into implantable cardiac rhythm management devices.

Current openFDA PMA Record#

Device: Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2DL DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI IC
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P980016
Supplement: S951
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
Decision date: 2026-04-30
Decision code: APPR
Date received: 2026-01-30
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for updates to the manufacturing acceptance conditions for plated through holes in hybrid subassemblies incorporated into implantable cardiac rhythm management devices.