En Trust ICD, Intrinsic ICD, Marquis DR & VR ICD, Maximo II DR ICD, Maximo II ICD, Maximo VR ICD, Protecta ICD /XT ICD,
FDA premarket approval P980016/S639 · decided 2017-10-25
Approval details
- PMA number
- P980016
- Supplement
- S639
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- En Trust ICD, Intrinsic ICD, Marquis DR & VR ICD, Maximo II DR ICD, Maximo II ICD, Maximo VR ICD, Protecta ICD /XT ICD,
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2017-09-01
- Decision date
- 2017-10-25
- Days to decision
- 54 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for several updates to the web-based battery longevity tool.
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