EVERA S DR ICD,EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, INTRINSIC 30 ICD,INTRINSIC ICD,MARQUIS DR ICD, MARQUIS
FDA premarket approval P980016/S478 · decided 2014-05-29
Approval details
- PMA number
- P980016
- Supplement
- S478
- 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, EVERA XT VR ICD, INTRINSIC 30 ICD,INTRINSIC ICD,MARQUIS DR ICD, MARQUIS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2014-03-28
- Decision date
- 2014-05-29
- Days to decision
- 62 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR MINOR HARDWARE AND FIRMWARE CHANGES TO THE MYCARELINK PATIENT MONITOR MODEL 24955 RF HEAD FOR THE DEVICES.
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