Evera MRI: DF-1 ICD, ICD; Evera S: DR ICD, VR ICD; Evera XT, DR ICD, VR ICD; Mirro MRI: DR ICD, VR ICD; Primo MRI: DR IC
FDA premarket approval P980016/S683 · decided 2018-09-05
Approval details
- PMA number
- P980016
- Supplement
- S683
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Evera MRI: DF-1 ICD, ICD; Evera S: DR ICD, VR ICD; Evera XT, DR ICD, VR ICD; Mirro MRI: DR ICD, VR ICD; Primo MRI: DR IC
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2018-08-08
- Decision date
- 2018-09-05
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Transition from battery grade raw material lithium to technical grade raw material lithium.
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