Evera MRI XT DR SureScan Model DDMB1D4, Evera MRI XT VR SureScan Model DVMB1DA, Evera MRI S DR SureScan Model DDMC3D4, E
FDA premarket approval P980016/S825 · decided 2022-08-26
Approval details
- PMA number
- P980016
- Supplement
- S825
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Evera MRI XT DR SureScan Model DDMB1D4, Evera MRI XT VR SureScan Model DVMB1DA, Evera MRI S DR SureScan Model DDMC3D4, E
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2022-06-17
- Decision date
- 2022-08-26
- Days to decision
- 70 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for addition of the summary for your Post Approval Study, Pacing Capture Threshold (PCT) Change Following 3T MRI Scan of MR Conditional CIEDs, to the labeling.
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