PMA P010031S929

Device: Cobalt MRI CRT-D (DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ); Cobalt XT MRI CRTD (DTPA2D1, DTPA2D4, DTPA2Q1, DTPA2QQ); Crome MR
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P010031
Supplement: S929
Product code: NIK
Decision date: 2026-07-31
Classification: Cardiovascular
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement: to implement additional sub-tier raw material suppliers and other minor process changes for components used in the hybrid subassemblies of Medtronic cardiac rhythm management (CRM) devices.

Current openFDA PMA Record#

Device: Cobalt MRI CRT-D (DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ); Cobalt XT MRI CRTD (DTPA2D1, DTPA2D4, DTPA2Q1, DTPA2QQ); Crome MR
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P010031
Supplement: S929
Product code: NIK
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date: 2026-07-31
Decision code: OK30
Date received: 2026-07-07
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to implement additional sub-tier raw material suppliers and other minor process changes for components used in the hybrid subassemblies of Medtronic cardiac rhythm management (CRM) devices.