PMA P010031S062
- Device
- CONCERTO ICD
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P010031
- Supplement
- S062
- Product code
- NIK
- Decision date
- 2007-03-15
- 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 DESIGN CHANGES TO THE BATTERY CONNECTOR MODULE FOR ENTRUST 35J, CONCERTO, AND VIRTUOSO ICDS.
Current openFDA PMA Record#
- Device
- CONCERTO ICD
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P010031
- Supplement
- S062
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2007-03-15
- Decision code
- APPR
- Date received
- 2007-01-16
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MINOR DESIGN CHANGES TO THE BATTERY CONNECTOR MODULE FOR ENTRUST 35J, CONCERTO, AND VIRTUOSO ICDS.