Concerto, Right Ventricular Lead Integrity Alert, Concerto II CRT-D. Consulta CRT-D, InSync II Marquis, II Protect, III
FDA premarket approval P010031/S554 · decided 2016-09-06
Approval details
- PMA number
- P010031
- Supplement
- S554
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Concerto, Right Ventricular Lead Integrity Alert, Concerto II CRT-D. Consulta CRT-D, InSync II Marquis, II Protect, III
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2016-06-24
- Decision date
- 2016-09-06
- Days to decision
- 74 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for enhancements to the Medtronic Model SW028 Baseline Operating System Software (BOSS) as well as the Vitatron Model VSH04 Desktop Application software running on the CareLink Encore 29901 Programmer.
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