Evera MRI, ICD, DF-1 ICD, S DR ICD, XT DR ICD, XT VR ICD; Mirro MRI DR ICD, VR ICD; Primo MRI DR ICD, VR ICD; Visia AF M
FDA premarket approval P980016/S690 · decided 2018-10-26
Approval details
- PMA number
- P980016
- Supplement
- S690
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Evera MRI, ICD, DF-1 ICD, S DR ICD, XT DR ICD, XT VR ICD; Mirro MRI DR ICD, VR ICD; Primo MRI DR ICD, VR ICD; Visia AF M
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2018-10-09
- Decision date
- 2018-10-26
- Days to decision
- 17 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Updates at the supplier to the Semi-Automate Feedthrough Inspection.
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