Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, and Evera XT VR ICD
FDA premarket approval P980016/S649 · decided 2018-01-31
Approval details
- PMA number
- P980016
- Supplement
- S649
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, and Evera XT VR ICD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2017-11-16
- Decision date
- 2018-01-31
- Days to decision
- 76 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for design changes to printed wiring boards and a supplier change for a select diode used in certain ICD and CRT-D devices.
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