Evera MRI ICD DDMB1D4, DDMC3D4; Evera S DR ICD DDBC3D1, DDBC3D4; Evera S VR ICD DVBC3D1; Evera XT DR ICD DDBB1D1, DDBB1D
FDA premarket approval P980016/S583 · decided 2016-04-22
Approval details
- PMA number
- P980016
- Supplement
- S583
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Evera MRI ICD DDMB1D4, DDMC3D4; Evera S DR ICD DDBC3D1, DDBC3D4; Evera S VR ICD DVBC3D1; Evera XT DR ICD DDBB1D1, DDBB1D
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2016-03-31
- Decision date
- 2016-04-22
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Add an alternate material for a manufacturing gauge tool.
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