SECURA DR & MAXIMO II DR & SECURA VR & MAXIMO II VR
FDA premarket approval P980016/S114 · decided 2008-03-17
Approval details
- PMA number
- P980016
- Supplement
- S114
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SECURA DR & MAXIMO II DR & SECURA VR & MAXIMO II VR
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2007-10-31
- Decision date
- 2008-03-17
- Days to decision
- 138 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR REMOVAL OF THE CONTRAINDICATION: ?PATIENTS WHOSE PRIMARY DISORDER IS BRADYARRHYTHMIA? AND FOR THE MEDTRONIC CONSULTA CRT-D D224TRK, MAXIMO II CRT-D D284TRK MEDTRONIC SECURA DR D224DRG, MEDTRONIC SECURA VR D224VRC, MAXIMO II DR D284DRG, MAXIMO II VR D284VRC, MODEL 9995 APPLICATION SOFTWARE VERSION 1.1 SYSTEMS, MEDTRONIC 2490C CARELINK MONITOR, 2020A CARDIOSIGHT READER AND 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME: M
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