Evera MRI, Evera XT DR ICD, Intrinsic 30 ICD, Marquis VR ICD, Maximo II ICD, Protecta ICD, Protecta XT ICD, Virtuoso II
FDA premarket approval P980016/S612 · decided 2017-06-09
Approval details
- PMA number
- P980016
- Supplement
- S612
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Evera MRI, Evera XT DR ICD, Intrinsic 30 ICD, Marquis VR ICD, Maximo II ICD, Protecta ICD, Protecta XT ICD, Virtuoso II
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2016-11-16
- Decision date
- 2017-06-09
- Days to decision
- 205 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for hardware, firmware, labeling, and manufacturing changes to support replacing the Bluetooth (BT) Classic module with a BT Low Energy module in the monitor base station.
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