- Device
- Amplia MRI CRT-D DTMB1D4 Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ Brava CRT-D DTBC1D4 Brava Quad CRT-D DTBC1Q1, DTBC1QQ Cl
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P010031
- Supplement
- S922
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2026-06-25
- Decision code
- APPR
- Date received
- 2026-03-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- a material change in the pulse generator header components of the Blackwell and Aurora device families, updates to the connector stiffness test method, and relocation of incoming inspection activities