Claria MRI/Claria MRI Quad CRT-D SureScan devices
FDA premarket approval P010031/S672 · decided 2019-08-23
Approval details
- PMA number
- P010031
- Supplement
- S672
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Claria MRI/Claria MRI Quad CRT-D SureScan devices
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2019-06-18
- Decision date
- 2019-08-23
- Days to decision
- 66 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for updated firmware and software for the EffectivCRT during AF feature.
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