Evera S DR/VR ICd, Evera XT DR/VR ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Mirro MRI DR/VR ICD, and Primo MRI DR/VR ICD
FDA premarket approval P980016/S722 · decided 2019-12-16
Approval details
- PMA number
- P980016
- Supplement
- S722
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Evera S DR/VR ICd, Evera XT DR/VR ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Mirro MRI DR/VR ICD, and Primo MRI DR/VR ICD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2019-10-15
- Decision date
- 2019-12-16
- Days to decision
- 62 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for RAMware updates to ICD and CRT-D devices and corresponding updates to the Medtronic CareLink 2090 Programmer Model SW016 and CareLink Encore 29901 Programmer Model SW033.
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