PMA P980016S663
- Device
- Evera MRI DF-1, Evera MRI ICD's; Mirro MIR DR, Mirro MIR VR ICD's; Primo MRI DR, Primo MRI VR ICD's; Visia AF MRI DF1, V
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S663
- Product code
- LWS
- Decision date
- 2018-06-05
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Approval for incorporating two new alternate integrated circuits into the circuitry of select Medtronic ICD and CRT-D devices.
Current openFDA PMA Record#
- Device
- Evera MRI DF-1, Evera MRI ICD's; Mirro MIR DR, Mirro MIR VR ICD's; Primo MRI DR, Primo MRI VR ICD's; Visia AF MRI DF1, V
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S663
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2018-06-05
- Decision code
- APPR
- Date received
- 2018-03-15
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for incorporating two new alternate integrated circuits into the circuitry of select Medtronic ICD and CRT-D devices.