Evera MRI; S DR,VR;XT DR,VR, ICD; Intrinsic 30 ICD; Marquis VR ICD; Maximo II ICD; Protecta XT ICD; Secura ICD; Virtuoso
FDA premarket approval P980016/S600 · decided 2016-11-17
Approval details
- PMA number
- P980016
- Supplement
- S600
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Evera MRI; S DR,VR;XT DR,VR, ICD; Intrinsic 30 ICD; Marquis VR ICD; Maximo II ICD; Protecta XT ICD; Secura ICD; Virtuoso
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2016-09-08
- Decision date
- 2016-11-17
- Days to decision
- 70 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for software modification to the MyCareLink Patient Monitor Model 24950.
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