PMA P010031S237
- Device
- CONCERTO II ICD/CONSULTA/MAXIMO II CRT-DS
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P010031
- Supplement
- S237
- Decision date
- 2011-03-24
- Approval order statement
- ADD A DRY PLASMA OXYGEN CLEAN PROCESS STEP.
Current openFDA PMA Record#
- Device
- CONCERTO II ICD/CONSULTA/MAXIMO II CRT-DS
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P010031
- Supplement
- S237
- Decision date
- 2011-03-24
- Decision code
- OK30
- Date received
- 2011-02-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADD A DRY PLASMA OXYGEN CLEAN PROCESS STEP.