LifeVest Wearable Defibrillator
FDA premarket approval P010030/S125 · decided 2019-09-03
Approval details
- PMA number
- P010030
- Supplement
- S125
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LifeVest Wearable Defibrillator
- Generic name
- Wearable automated external defibrillator
- Applicant
- Zoll Manufacturing Corporation
- Date received
- 2019-08-29
- Decision date
- 2019-09-03
- Days to decision
- 5 days
- Decision code
- OK30
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pittsburgh, PA
- Statement
- Replace the cleaning solvent used during the manufacture of the therapy electrodes and addition of distilled water to the cleaning process.
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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 |