PMA P980016S671
- Device
- Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XR DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S671
- Product code
- LWS
- Decision date
- 2018-05-16
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Update the TEMPO software that is used to apply, collect, and record data from the Helium Leak Test on batteries and capacitors.
Current openFDA PMA Record#
- Device
- Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XR DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S671
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2018-05-16
- Decision code
- OK30
- Date received
- 2018-04-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update the TEMPO software that is used to apply, collect, and record data from the Helium Leak Test on batteries and capacitors.