CONSULTA CRT-D, MAXIMO II CRT-D, & VARIOUS FAMILIES/MODELS OF CONCERTO, INSYNC, & PROTECTA
FDA premarket approval P010031/S277 · decided 2011-11-17
Approval details
- PMA number
- P010031
- Supplement
- S277
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CONSULTA CRT-D, MAXIMO II CRT-D, & VARIOUS FAMILIES/MODELS OF CONCERTO, INSYNC, & PROTECTA
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2011-09-19
- Decision date
- 2011-11-17
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR AN UPDATE TO THE OPERATING SYSTEM SOFTWARE FOR THE CARELINK PROGRAMMER ASSOCIATED WITH MEDTRONIC PACEMAKER, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), AND CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICES APPROVED UNDER THE REFERENCED PMA.
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