VIRTUOSO MODELS D154AWG/D154VWC
FDA premarket approval P980016/S090 · decided 2007-02-15
Approval details
- PMA number
- P980016
- Supplement
- S090
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VIRTUOSO MODELS D154AWG/D154VWC
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- 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
- LWS
- 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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