PMA P010031S554
- Device
- Concerto, Right Ventricular Lead Integrity Alert, Concerto II CRT-D. Consulta CRT-D, InSync II Marquis, II Protect, III
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P010031
- Supplement
- S554
- Product code
- NIK
- Decision date
- 2016-09-06
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order 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.
Current openFDA PMA Record#
- Device
- Concerto, Right Ventricular Lead Integrity Alert, Concerto II CRT-D. Consulta CRT-D, InSync II Marquis, II Protect, III
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P010031
- Supplement
- S554
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2016-09-06
- Decision code
- APPR
- Date received
- 2016-06-24
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.