LIFEVEST WEARABLE DEFIBRILLATOR
FDA premarket approval P010030/S051 · decided 2014-07-14
Approval details
- PMA number
- P010030
- Supplement
- S051
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LIFEVEST WEARABLE DEFIBRILLATOR
- Generic name
- Wearable automated external defibrillator
- Applicant
- Zoll Manufacturing Corporation
- Date received
- 2014-05-12
- Decision date
- 2014-07-14
- Days to decision
- 63 days
- Decision code
- APPR
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pittsburgh, PA
- Statement
- APPROVAL FOR A SOFTWARE CHANGE THAT WILL ENABLE ANANALOG CLIPPING NOISE DETECTOR WHICH WILL ALLOW THE SYSTEM TO BETTER RECOGNIZE WHEN AN INPUT SIGNAL MAY BE COMPROMISED DUE TO SATURATION OF ANALOG AMPLIFIERS IN THE ECG SIGNAL PROCESSING CIRCUITRY.
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