VIVA, BRAVA, PROTECTA, PROTECTA XT, CONCERTO, CONCERTO II, CONSULTA, MAXIMO II, INSYNC II PROTECT
FDA premarket approval P010031/S524 · decided 2016-02-22
Approval details
- PMA number
- P010031
- Supplement
- S524
- 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
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2015-12-18
- Decision date
- 2016-02-22
- Days to decision
- 66 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for firmware updates to the MyCareLink patient home monitor.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.