Evera MRI ICD, Evera S DR/ S VR ICD's; Evera XT DR ICD/ XT VR ICD; Maximo II ICD; Protecta VR/XT ICD; Secura DR ICD, Sec
FDA premarket approval P980016/S626 · decided 2017-03-30
Approval details
- PMA number
- P980016
- Supplement
- S626
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Evera MRI ICD, Evera S DR/ S VR ICD's; Evera XT DR ICD/ XT VR ICD; Maximo II ICD; Protecta VR/XT ICD; Secura DR ICD, Sec
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2017-03-08
- Decision date
- 2017-03-30
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Change to the monitoring frequency for the battery header laser weld inspection.
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