PMA P010031S905

Device: Cobalt MRI CRT-D DTPB2D1, DTPB2D4 NIK Cobalt XT MRI CRT-D DTPA2D1, DTPA2D4 NIK Crome MRI CRT-D DTPC2D1, DTPC2D4
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P010031
Supplement: S905
Product code: NIK
Decision date: 2025-12-19
Classification: Cardiovascular
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement: approval for a material change in the pulse generator header components of select CRT-D and CRT-P devices.

Current openFDA PMA Record#

Device: Cobalt MRI CRT-D DTPB2D1, DTPB2D4 NIK Cobalt XT MRI CRT-D DTPA2D1, DTPA2D4 NIK Crome MRI CRT-D DTPC2D1, DTPC2D4
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P010031
Supplement: S905
Product code: NIK
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date: 2025-12-19
Decision code: APPR
Date received: 2025-09-25
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for a material change in the pulse generator header components of select CRT-D and CRT-P devices.