LifeVest Wearable Defibrillator
FDA premarket approval P010030/S138 · decided 2020-08-04
Approval details
- PMA number
- P010030
- Supplement
- S138
- 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
- 2020-05-08
- Decision date
- 2020-08-04
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pittsburgh, PA
- Statement
- Approval for a mechanical design change to the LifeVest 4000 and HWD 1000 Monitor to improve the ruggedness of the Electrode Belt connector.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |