EVERA S DR ICD; EVERA S VR ICD; EVERA XT DR ICD; EVERA XT VR ICD
FDA premarket approval P980016/S437 · decided 2013-10-29
Approval details
- PMA number
- P980016
- Supplement
- S437
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EVERA S DR ICD; EVERA S VR ICD; EVERA XT DR ICD; EVERA XT VR ICD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2013-09-04
- Decision date
- 2013-10-29
- Days to decision
- 55 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A MINOR DESIGN CHANGE IN THE MULTILAYER CERAMIC CAPACITORS MADE BY A SECOND TIER SUPPLIER WHICH ARE USED IN THE DEVICES.
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