PMA P010031S230
- Device
- CONCERTO II/MAXIMO II/CONSULTA CRT-DS
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P010031
- Supplement
- S230
- Decision date
- 2011-02-10
- Approval order statement
- UPDATES TO TEST SOFTWARE USED DURING FINAL FUNCTIONAL DEVICE TESTING.
Current openFDA PMA Record#
- Device
- CONCERTO II/MAXIMO II/CONSULTA CRT-DS
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P010031
- Supplement
- S230
- Decision date
- 2011-02-10
- Decision code
- OK30
- Date received
- 2011-01-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- UPDATES TO TEST SOFTWARE USED DURING FINAL FUNCTIONAL DEVICE TESTING.