WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 4000 LIFEVEST
FDA premarket approval P010030/S074 · decided 2016-07-18
Approval details
- PMA number
- P010030
- Supplement
- S074
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 4000 LIFEVEST
- Generic name
- Wearable automated external defibrillator
- Applicant
- Zoll Manufacturing Corporation
- Date received
- 2016-04-19
- Decision date
- 2016-07-18
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pittsburgh, PA
- Statement
- Approval for a larger capacity battery pack and associated modifications to the battery pack connection to the printed circuit assembly (PCA) for the WCD 4000 System. This device is indicated for patients of all ages who are at risk for sudden cardiac arrest and either not candidates for or refuse an implantable defibrillator.
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