PMA P010031S320
- Device
- CONCERTO II CRT-D, CONSULTA DF4 ICD, ICD, MAXIMO IICRT-D, MAXIMO IIDF4 CRT-D
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P010031
- Supplement
- S320
- Decision date
- 2012-08-10
- Approval order statement
- UPDATES TO THE NEXT GENERATION HYBRID TESTER SOFTWARE.
Current openFDA PMA Record#
- Device
- CONCERTO II CRT-D, CONSULTA DF4 ICD, ICD, MAXIMO IICRT-D, MAXIMO IIDF4 CRT-D
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P010031
- Supplement
- S320
- Decision date
- 2012-08-10
- Decision code
- OK30
- Date received
- 2012-07-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- UPDATES TO THE NEXT GENERATION HYBRID TESTER SOFTWARE.