LIFEVEST WEARABLE DEFIBRILLATOR
FDA premarket approval P010030/S037 · decided 2012-12-20
Approval details
- PMA number
- P010030
- Supplement
- S037
- 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
- 2012-10-18
- Decision date
- 2012-12-20
- Days to decision
- 63 days
- Decision code
- APPR
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pittsburgh, PA
- Statement
- APPROVAL FOR A MINOR CHANGE IN SOFTWARE/FIRMWARE FOR YOUR LIFEVESTWEARABLE DEFIBRILLATOR (WCD 4000) DEVICE TO SUPPORT TWO FDA APPROVED ACCELEROMETERS. THE SOFTWARE/FIRMWARE CHANGE ENABLES THE SUBJECT DEVICE TO DETECT BETWEEN THE ACCELEROMETERS, TO CALIBRATE THE ACCELEROMETER AND ADJUST FOR ACCELEROMETER OUTPUT POLARITY.
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