Amplia MRI and Amplia MRI Quad CRT-D SureScan , Compia MRI and Compia MRI Quad CRT-D SureScan, Claria MRI and Claria MRI
FDA premarket approval P010031/S569 · decided 2017-04-25
Approval details
- PMA number
- P010031
- Supplement
- S569
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Amplia MRI and Amplia MRI Quad CRT-D SureScan , Compia MRI and Compia MRI Quad CRT-D SureScan, Claria MRI and Claria MRI
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2016-11-02
- Decision date
- 2017-04-25
- Days to decision
- 174 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval of 1.5 and 3T MR Conditional Labeling for SelectSecure MRI SureScan Lead Model 3830.
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