Claria MRI Quad CRT-D SureScan, Amplia MRI Quad CRT-D, Implantable Cardioverter Defibrillators with Cardiac Resynchroniz
FDA premarket approval P010031/S563 · decided 2017-03-24
Approval details
- PMA number
- P010031
- Supplement
- S563
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Claria MRI Quad CRT-D SureScan, Amplia MRI Quad CRT-D, Implantable Cardioverter Defibrillators with Cardiac Resynchroniz
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2016-09-26
- Decision date
- 2017-03-24
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for the dual cathode left ventricular (LV) pacing feature for the Claria MRI Quad CRT-D SureScan and the Amplia MRI Quad CRT-D SureScan devices.
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