EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO I
FDA premarket approval P980016/S513 · decided 2015-01-30
Approval details
- PMA number
- P980016
- Supplement
- S513
- Supplement type
- Real-Time Process
- Trade name
- EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO I
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2014-12-18
- Decision date
- 2015-01-30
- Days to decision
- 43 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A MINOR DESIGN TOLERANCE CHANGE AND ASSOCIATEDINSPECTION PROCEDURE CHANGES FOR MULTIPOLAR FEEDTHROUGH INSULATORS FOR SELECTED IMPLANTABLECARDIOVERTER DEFIBRILLATORS AND CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATORS.
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