PMA P010031S439
- Device
- BRAVA CRT-D, CONCERTO ICD,CONCERTO II CRT-D,CONSULTA ICD,INSYNC II PROTECT ICD,INSYNC III MARQUIS ICD, INSYNC MAXIMO ICD
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P010031
- Supplement
- S439
- Product code
- NIK
- Decision date
- 2014-05-29
- 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 MINOR HARDWARE AND FIRMWARE CHANGES TO THE MYCARELINK PATIENT MONITOR MODEL 24955 RF HEAD FOR THE DEVICES.
Current openFDA PMA Record#
- Device
- BRAVA CRT-D, CONCERTO ICD,CONCERTO II CRT-D,CONSULTA ICD,INSYNC II PROTECT ICD,INSYNC III MARQUIS ICD, INSYNC MAXIMO ICD
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P010031
- Supplement
- S439
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2014-05-29
- Decision code
- APPR
- Date received
- 2014-03-28
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MINOR HARDWARE AND FIRMWARE CHANGES TO THE MYCARELINK PATIENT MONITOR MODEL 24955 RF HEAD FOR THE DEVICES.