LIFEVEST (WCD 3100) DEVICE
FDA premarket approval P010030/S007 · decided 2006-11-01
Approval details
- PMA number
- P010030
- Supplement
- S007
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LIFEVEST (WCD 3100) DEVICE
- Generic name
- Wearable automated external defibrillator
- Applicant
- Zoll Manufacturing Corporation
- Date received
- 2006-03-06
- Decision date
- 2006-11-01
- Days to decision
- 240 days
- Decision code
- APPR
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pittsburgh, PA
- Statement
- APPROVAL FOR HARDWARE CHANGE TO INTEGRATE THE PENDANT ALARM MODULE INTO THE MONITOR ENCLOSURE, HARDWARE CHANGE TO THE COMPUTER/ANALOG PRINTED CIRCUIT ASSEMBLY TO IMPROVE EMI IMMUNITY AND REPLACE SEVERAL OBSOLETE COMPONENTS, SOFTWARE CHANGES TO INTERACT WITH THE REVISED COMPUTER/ANALOG PRINTED CIRCUIT ASSEMBLY, LABELING CHANGES TO ACCOMMODATE THE INTEGRATED ALARM MODULE, AND TO IMPROVE READABILITY, LABELING CHANGES TO PROVIDE A SPANISH VERSION OF THE PATIENT MANUAL, PATIENT CHECKLIST, AND CORRESP
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