Evera MRI XT DR /VR SureScan; Evera MRI S DR/VR SureScan; Visia AF MRI XT Surescan; Visia AF MRI S VR Surescan DVFC3D4 A
FDA premarket approval P980016/S609 · decided 2017-04-25
Approval details
- PMA number
- P980016
- Supplement
- S609
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Evera MRI XT DR /VR SureScan; Evera MRI S DR/VR SureScan; Visia AF MRI XT Surescan; Visia AF MRI S VR Surescan DVFC3D4 A
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2016-11-02
- Decision date
- 2017-04-25
- Days to decision
- 174 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval of 1.5 and 3T MR Conditional Labeling for SelectSecure MRI SureScan Lead Model 3830.
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