CONCERTO, INSYNC, MACIMO, PROTECTA AND VIVA FAMILIES AND BRAVA CRTS-D'S
FDA premarket approval P010031/S505 · decided 2015-08-17
Approval details
- PMA number
- P010031
- Supplement
- S505
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CONCERTO, INSYNC, MACIMO, PROTECTA AND VIVA FAMILIES AND BRAVA CRTS-D'S
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2015-07-02
- Decision date
- 2015-08-17
- Days to decision
- 46 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR AN UPDATE TO THE 2090 CARELINK PROGRAMMER DESKTOP SOFTWARE MODEL 9986.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.