MAXIMO II, SECURA & VIRTUOSO II DR/VR ICDS
FDA premarket approval P980016/S343 · decided 2012-06-04
Approval details
- PMA number
- P980016
- Supplement
- S343
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MAXIMO II, SECURA & VIRTUOSO II DR/VR ICDS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-03-07
- Decision date
- 2012-06-04
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR MAXIMO II ICD MODELS D264DRM, D284DRG, D284VRC; SECURA ICD MODELS D204DRM, D224DRG, D224VRC; AND VIRTUOSO II DR/VR ICD MODELS D274DRG AND D274VRC.
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