MEDTRONIC SECURA & MAXIMO II ICDS
FDA premarket approval P980016/S127 · decided 2008-07-11
Approval details
- PMA number
- P980016
- Supplement
- S127
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC SECURA & MAXIMO II ICDS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2008-04-10
- Decision date
- 2008-07-11
- Days to decision
- 92 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE INC. 3 RAMWARE, WHICH CONTAINS A DESIGN CHANGE TO ADDRESS AN ISSUE WITH THE L409 INTEGRATED CIRCUIT (IC) IN THE CONSULTA CRT-D D224TRK, MAXIMO II CRT-D D284TRK IMPLANTABLE CARDIOVERTER DEFIBRILLATORS WITH CARDIAC RESYNCHRONIZATION, SECURA DR D224DRG AND SECURA VR D224VRC, MAXIMO II DR D284DRG AND MAXIMO II VR D284VRC IMPLANTABLE CARDIOVERTER DEFIBRILLATORS.
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