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
FDA premarket approval P980016/S663 · decided 2018-06-05
Approval details
- PMA number
- P980016
- Supplement
- S663
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- 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
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2018-03-15
- Decision date
- 2018-06-05
- Days to decision
- 82 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for incorporating two new alternate integrated circuits into the circuitry of select Medtronic ICD and CRT-D devices.
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