PMA P010031S918

Device: Cobalt MRI CRT-D (DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ); Cobalt XT MRI CRT-D (DTPA2D1, DTPA2D4, DTPA2Q1, DTPA2QQ); Crome M
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P010031
Supplement: S918
Product code: NIK
Decision date: 2026-04-30
Classification: Cardiovascular
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
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 CRT-D (DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ); Cobalt XT MRI CRT-D (DTPA2D1, DTPA2D4, DTPA2Q1, DTPA2QQ); Crome M
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P010031
Supplement: S918
Product code: NIK
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
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.