CONSULTA CRT-D, MAXIMO II CRT-D AND CONCERTO II CRT-D
FDA premarket approval P010031/S131 · decided 2009-03-31
Approval details
- PMA number
- P010031
- Supplement
- S131
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CONSULTA CRT-D, MAXIMO II CRT-D AND CONCERTO II CRT-D
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2008-10-22
- Decision date
- 2009-03-31
- Days to decision
- 160 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE MODEL 9995 V1.2 APPLICATION SOFTWARE WHICH INCLUDES THE LEAD INTEGRITY ALERT FEATURE AND ADDITIONAL SOFTWARE UPDATES.
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