PMA P980016S960

Device: Cobalt MRI ICD DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4; Cobalt XT MRI ICD DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4; Crome MRI ICD D
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P980016
Supplement: S960
Product code: LWS
Decision date: 2026-07-22
Classification: Cardiovascular
Generic name: Implantable cardioverter defibrillator (non-CRT)
Approval order statement: implementing an automated vision inspection system and supporting manufacturing process controls for antenna alignment verification during connector module assembly

Current openFDA PMA Record#

Device: Cobalt MRI ICD DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4; Cobalt XT MRI ICD DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4; Crome MRI ICD D
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P980016
Supplement: S960
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
Decision date: 2026-07-22
Decision code: OK30
Date received: 2026-06-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: implementing an automated vision inspection system and supporting manufacturing process controls for antenna alignment verification during connector module assembly