EVERA S(DR/VR) ICD, EVERA XT (DR/VR) ICD, MAXIMO II ICD, PROTECTA (XT)ICD,SECURA ICD, VIRTUOUSO II(DR/VR) ICD
FDA premarket approval P980016/S526 · decided 2015-03-04
Approval details
- PMA number
- P980016
- Supplement
- S526
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EVERA S(DR/VR) ICD, EVERA XT (DR/VR) ICD, MAXIMO II ICD, PROTECTA (XT)ICD,SECURA ICD, VIRTUOUSO II(DR/VR) ICD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2015-02-04
- Decision date
- 2015-03-04
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- ADD ALTERNATIVE ULTRAVIOLET (UV) IRRADIATOR EQUIPMENT IN THE MANUFACTURING PROCESS FOR THE DEVICES.
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