CONCERTO MODEL C154DWK IMPLANTABLE DEVICES
FDA premarket approval P010031/S058 · decided 2007-02-15
Approval details
- PMA number
- P010031
- Supplement
- S058
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CONCERTO MODEL C154DWK IMPLANTABLE DEVICES
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2006-11-28
- Decision date
- 2007-02-15
- Days to decision
- 79 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR FIRMWARE UPDATES TO 1) ADDRESS A ?SOFT? RATE LIMIT POWER ON RESET, 2) LOAD A TEMPERATURE SENSITIVITY UPDATE AT THE TIME OF MANUFACTURING, AND 3) LOAD OPTIVOL ENHANCEMENTS (FOR USE OUTSIDE OF THE UNITED STATES ONLY) AT THE TIME OF MANUFACTURING.
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