MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUISI II DR/VR ICD
FDA premarket approval P980016/S559 · decided 2015-11-25
Approval details
- PMA number
- P980016
- Supplement
- S559
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUISI II DR/VR ICD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2015-10-22
- Decision date
- 2015-11-25
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE L409 IC DESIGN AND ASSOCIATED MANUFACTURINGCHANGES, WHICH IS USED IN THE DEVICES.
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