WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST
FDA premarket approval P010030/S191 · decided 2025-05-30
Approval details
- PMA number
- P010030
- Supplement
- S191
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST
- Generic name
- Wearable automated external defibrillator
- Applicant
- Zoll Manufacturing Corporation
- Date received
- 2025-03-03
- Decision date
- 2025-05-30
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pittsburgh, PA
- Statement
- Approval for implementation of a software update to the LifeVest 5100 Monitor and Electrode Belt software to software version V0006
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ZOLL Arrhythmia Management Sysyem (K190939) | Zoll Manufacturing Corporation | 2019-12-19 |
| ZOLL ECG Analysis Software (K182093) | Zoll Manufacturing Corporation | 2019-01-28 |
| µCor Heart Failure and Arrhythmia Management System (K172510) | Zoll Manufacturing Corporation | 2018-05-11 |