MEDTRONIC CONCERTO CRT-D MODEL C154DWK
FDA premarket approval P010031/S070 · decided 2007-06-06
Approval details
- PMA number
- P010031
- Supplement
- S070
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC CONCERTO CRT-D MODEL C154DWK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2007-05-16
- Decision date
- 2007-06-06
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A CHANGE IN THE BAROMETRIC PRESSURE REQUIREMENT FROM 6 ATMOSPHERES ABSOLUTE (ATA) TO 4 ATA AND A CHANGE IN BAROMETRIC PRESSURE TESTING METHODOLOGY USED DURING DESIGN VERIFICATION.
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