Amplia MRI and Amplia MRI Quad CRT-D SureScan, Compia MRI and Compia MRI Quad CRT-D SureScan and Claria MRI and Claria M
FDA premarket approval P010031/S626 · decided 2018-06-28
Approval details
- PMA number
- P010031
- Supplement
- S626
- 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 and Claria MRI and Claria M
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2018-04-13
- Decision date
- 2018-06-28
- Days to decision
- 76 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for an update to the indications for use to include pacing at the bundle of His. The device, as modified, will be marketed under the trade name SelectSecure MRI SureScan Lead Model 3830 and is indicated for: The Model 3830 lead is intended for pacing and sensing in the atrium or right ventricle. It is also intended for pacing and sensing at the bundle of His as an alternative to right ventricular pacing in a single or dual chamber pacing system.
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