CONCERTO/CONCERTO II CRT-D/CONSULTA CRT-D/MAXIMO II CRT-D
FDA premarket approval P010031/S132 · decided 2009-05-01
Approval details
- PMA number
- P010031
- Supplement
- S132
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CONCERTO/CONCERTO II CRT-D/CONSULTA CRT-D/MAXIMO II CRT-D
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2008-11-04
- Decision date
- 2009-05-01
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR DESIGN AND MANUFACTURING PROCESS MODIFICATIONS TO THE EXISTING MEDTRONIC CARELINK MONITOR MODEL 2490C TO PRODUCE THE 2490C LOW COST MONITOR.
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