LifeVest Wearable Defibrillator
FDA premarket approval P010030/S134 · decided 2020-04-18
Approval details
- PMA number
- P010030
- Supplement
- S134
- 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
- 2020-04-01
- Decision date
- 2020-04-18
- Days to decision
- 17 days
- Decision code
- OK30
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pittsburgh, PA
- Statement
- Change in the manufacturing location of the supplier for the Electrode Belt Therapy foam cover for the LifeVest 4000 and LifeVest 4000B.
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 |