LIFEVEST WEARABLE DEFIBRILLATOR
FDA premarket approval P010030/S049 · decided 2014-05-19
Approval details
- PMA number
- P010030
- Supplement
- S049
- 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
- 2014-03-25
- Decision date
- 2014-05-19
- Days to decision
- 55 days
- Decision code
- APPR
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pittsburgh, PA
- Statement
- APPROVAL FOR 29 ROHS COMPLIANT ALTERNATE COMPONENTS, 7 ROHS COMPLIANT ALTERNATE BARE-BOARD SUBASSEMBLIES, AND 6 ROHS COMPLIANT ALTERNATE CABLE SUBASSEMBLIES FOR USE IN THE LIFEVEST WEARABLE DEFIBRILLATOR.
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510(k) clearances by this applicant
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|---|---|---|
| ZOLL Arrhythmia Management Sysyem (K190939) | Zoll Manufacturing Corporation | 2019-12-19 |
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| µCor Heart Failure and Arrhythmia Management System (K172510) | Zoll Manufacturing Corporation | 2018-05-11 |