Amplia MRI CRT-D DTMB1D1, DTMB1D4; Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ; Brava CRT-D DTBC1D4, Brava CRT-D DTBC1D1; Bra
FDA premarket approval P010031/S892 · decided 2025-07-09
Approval details
- PMA number
- P010031
- Supplement
- S892
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Amplia MRI CRT-D DTMB1D1, DTMB1D4; Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ; Brava CRT-D DTBC1D4, Brava CRT-D DTBC1D1; Bra
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2025-05-20
- Decision date
- 2025-07-09
- Days to decision
- 50 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- approval for minor design changes to the final filtered feedthrough assemblies for Implantable Cardioverter Defibrillators (ICDs) and Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-Ds)
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