CONCERTO II/CONSULTA/MAXIMO II
FDA premarket approval P010031/S260 · decided 2011-07-15
Approval details
- PMA number
- P010031
- Supplement
- S260
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CONCERTO II/CONSULTA/MAXIMO II
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2011-06-10
- Decision date
- 2011-07-15
- Days to decision
- 35 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- SIX CHANGES TO GEN2 HYBRID TESTER: 1) A CHANGE TO THE TEST DECIBEL LIMIT OF THE EGM CMR; 2) A CHANGE TO THE TELEMETRY B VIZSENSE; 3) A CHANGE TO THE R034 STRESS; 4) A CHANGE TO THE JTAG FULL ENERGY DELIVERY PULSE WIDTH; 5) A CHANGE TO LV1 CONTINUITY; AND 6) A CHANGE TO THE CURRENT DRAIN AVVD RF IDD.
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