Amplia MRI CRT-D/ Amplia MRI Quad CRT-D; Brava CRT-D/ Brava Quad CRT-D; Claria MRI CRT-D. Claria MRI CRT-D; Compia MRI C
FDA premarket approval P010031/S601 · decided 2017-12-01
Approval details
- PMA number
- P010031
- Supplement
- S601
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Amplia MRI CRT-D/ Amplia MRI Quad CRT-D; Brava CRT-D/ Brava Quad CRT-D; Claria MRI CRT-D. Claria MRI CRT-D; Compia MRI C
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2017-09-05
- Decision date
- 2017-12-01
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for firmware changes to the CareLink Express Monitor Model 2020B and CardioSight Reader Model 2020A.
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