Evera MRI DF-1 ICD DVMB1D1, DDMB1D1, DDMC3D1, DVMC3D1; Evera MRI ICD DDMC3D4, DVMB1D4, DVMC3D4, DDMB1D4; Evera S DR ICD
FDA premarket approval P980016/S633 · decided 2017-06-08
Approval details
- PMA number
- P980016
- Supplement
- S633
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Evera MRI DF-1 ICD DVMB1D1, DDMB1D1, DDMC3D1, DVMC3D1; Evera MRI ICD DDMC3D4, DVMB1D4, DVMC3D4, DDMB1D4; Evera S DR ICD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2017-05-18
- Decision date
- 2017-06-08
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Additional vision system for inspection of final packaged devices.
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