PMA P010031S910

Device: Amplia MRI CRT-D (DTMB1D1, DTMB1D4); Amplia MRI Quad CRT-D (DTMB1Q1, DTMB1QQ); Brava CRT-D (DTBC1D1, DTBC1D4); Brava Qua
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P010031
Supplement: S910
Product code: NIK
Decision date: 2025-12-03
Classification: Cardiovascular
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement: to implement an alternate supplier of a carbon ink component used in ICD and CRT-D capacitor assemblies

Current openFDA PMA Record#

Device: Amplia MRI CRT-D (DTMB1D1, DTMB1D4); Amplia MRI Quad CRT-D (DTMB1Q1, DTMB1QQ); Brava CRT-D (DTBC1D1, DTBC1D4); Brava Qua
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P010031
Supplement: S910
Product code: NIK
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date: 2025-12-03
Decision code: OK30
Date received: 2025-11-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to implement an alternate supplier of a carbon ink component used in ICD and CRT-D capacitor assemblies