Amplia MRI CRTD DTMB1D1; Amplia MRI Quad CRT-D DTMB1Q1; Brava CRT-D DTBC1D1; Brava Quad CRTD DTBC1Q1; Claria MRI CRT-D D
FDA premarket approval P010031/S889 · decided 2025-06-05
Approval details
- PMA number
- P010031
- Supplement
- S889
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Amplia MRI CRTD DTMB1D1; Amplia MRI Quad CRT-D DTMB1Q1; Brava CRT-D DTBC1D1; Brava Quad CRTD DTBC1Q1; Claria MRI CRT-D D
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2025-05-07
- Decision date
- 2025-06-05
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- to add an inspection step within the connector module manufacturing process at the Medtronic Energy and Component Center (MECC)
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