CLARIA MRI CRT-D SURESCAN MODEL DTMA1D4; QUAD MODEL DTMA1QQ; MODEL DTMA1D1, MODEL DTMBIQ1, MODEL DTMB1Q1,MODEL DTMC1D1,
FDA premarket approval P010031/S550 · decided 2016-10-25
Approval details
- PMA number
- P010031
- Supplement
- S550
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CLARIA MRI CRT-D SURESCAN MODEL DTMA1D4; QUAD MODEL DTMA1QQ; MODEL DTMA1D1, MODEL DTMBIQ1, MODEL DTMB1Q1,MODEL DTMC1D1,
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2016-05-03
- Decision date
- 2016-10-25
- Days to decision
- 175 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for the Claria MRI/Claria MRI Quad CRT-D SureScan devices as well as the Amplia MRI/Amplia MRI Quad CRT-D SureScan and Compia MRI CRT-D SureScan device models with DF-1 connector compatibility.
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