MAXIMO DR/ VR MODEL 7278 AND 7232 ICD SYSTEMS
FDA premarket approval P980016/S060 · decided 2006-02-01
Approval details
- PMA number
- P980016
- Supplement
- S060
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MAXIMO DR/ VR MODEL 7278 AND 7232 ICD SYSTEMS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2005-10-12
- Decision date
- 2006-02-01
- Days to decision
- 112 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE MODEL 90001 EGMP5 DOWNLOAD APPLICATION USED MEDTRONIC MAXIMO DR/VR MODELS 7278 AND 7232 ICD SYSTEMS.
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