AMPLIA MRI/AMPLIA MRI QUAD CRT-D SURESCAN; COMPIA MRI/COMPIA MRI QUAD CRT-D SURESCAN
FDA premarket approval P010031/S513 · decided 2016-02-01
Approval details
- PMA number
- P010031
- Supplement
- S513
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AMPLIA MRI/AMPLIA MRI QUAD CRT-D SURESCAN; COMPIA MRI/COMPIA MRI QUAD CRT-D SURESCAN
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2015-09-24
- Decision date
- 2016-02-01
- Days to decision
- 130 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for the Amplia MRI/Amplia MRI Quad CRT-D SureScan and Compia MRI/Compia MRI Quad CRT-D SureScan devices, programmer application software Model SW034 and extension of MR Conditional labeling for the Attain Ability and Attain Performa lead models as MRI SureScan labeled leads.
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