Viva, Brava, Protecta, Protecta XT, COncerto, Concerto II, Consulta, Maximo II, InSync II Protect, Amplia, Compia and Cl
FDA premarket approval P010031/S644 · decided 2018-10-18
Approval details
- PMA number
- P010031
- Supplement
- S644
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Viva, Brava, Protecta, Protecta XT, COncerto, Concerto II, Consulta, Maximo II, InSync II Protect, Amplia, Compia and Cl
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2018-08-22
- Decision date
- 2018-10-18
- Days to decision
- 57 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for updates to the remote monitoring systems for Attesta and Sphera MRI SureScan IPG devices.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.