LIFEVEST WEARABLE DEFIBRILLATOR
FDA premarket approval P010030/S024 · decided 2011-02-18
Approval details
- PMA number
- P010030
- Supplement
- S024
- 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
- 2010-09-07
- Decision date
- 2011-02-18
- Days to decision
- 164 days
- Decision code
- APPR
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pittsburgh, PA
- Statement
- APPROVAL FOR SOFTWARE CHANGES INCLUDING ASYSTOLE NOTIFICATION HANDLING, LOW BATTERY NOTIFICATION HANDLING, AND POWER UP RESPONSE BUTTON SEQUENCE IN ADDITION TO LABELING UPDATES RESULTING FROM THOSE CHANGES.
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