INSYNC MARQUIS/SENTRY/MAXIMO/CONCERTO CRT-ICDS
FDA premarket approval P010031/S069 · decided 2007-06-25
Approval details
- PMA number
- P010031
- Supplement
- S069
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INSYNC MARQUIS/SENTRY/MAXIMO/CONCERTO CRT-ICDS
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2007-04-24
- Decision date
- 2007-06-25
- Days to decision
- 62 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE L325-03 AND L325-04 INTEGRATED CIRCUIT (IC) TO MINIMIZE THE POTENTIAL FOR A GATE-OXIDE BREAKDOWN WITHIN THE L325-01, L325-02, AND L281-04 ICS.
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