CONCERTO CRT-D/CONSULTA CRT-D/MAXIMO II CRT-D/CONCERTO II CRT-D
FDA premarket approval P010031/S151 · decided 2009-04-15
Approval details
- PMA number
- P010031
- Supplement
- S151
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CONCERTO CRT-D/CONSULTA CRT-D/MAXIMO II CRT-D/CONCERTO II CRT-D
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2009-03-16
- Decision date
- 2009-04-15
- Days to decision
- 30 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- CHANGES TO THE HYBRID AND FINAL TEST FOR THE DEVICE.
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