Amplia MRI Quad CRT-D SureScan, Compia MRI Quad CRT-D SureScan, Claria MRI Quad CRT-D SureScan and Implantable Defibrill
FDA premarket approval P010031/S654 · decided 2019-04-10
Approval details
- PMA number
- P010031
- Supplement
- S654
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Amplia MRI Quad CRT-D SureScan, Compia MRI Quad CRT-D SureScan, Claria MRI Quad CRT-D SureScan and Implantable Defibrill
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2018-10-26
- Decision date
- 2019-04-10
- Days to decision
- 166 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for the Attain Stability Quad MRI SureScan Model 4798 left ventricular (LV) lead.
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