- Device
- Cobalt XT HF Quad CRT-D MRI SureScan (DTPA2QQ, DTPA2Q1); Cobalt XT HF CRT-D MRI SureScan (DTPA2D4 and DTPA2Dl); Cobalt H
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P010031
- Supplement
- S674
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2020-04-23
- Decision code
- APPR
- Date received
- 2019-07-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for Cobalt XT, Cobalt, and Crome MRI SureScan Implantable Cardioverter Defibrillator (ICD) and ICD with Cardiac Resynchronization (CRT-D) Systems.