Evera MRI DF-1 ICD, Evera MRI ICD, Evera S MRI ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD
FDA premarket approval P010031/S699 · decided 2020-04-23
Approval details
- PMA number
- P010031
- Supplement
- S699
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Evera MRI DF-1 ICD, Evera MRI ICD, Evera S MRI ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2020-03-25
- Decision date
- 2020-04-23
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Implement a modified prebake process at supplier.
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