LIFEVEST WEARABLE DEFIBRILLATOR
FDA premarket approval P010030/S054 · decided 2015-11-06
Approval details
- PMA number
- P010030
- Supplement
- S054
- 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
- 2014-07-11
- Decision date
- 2015-11-06
- Days to decision
- 483 days
- Decision code
- APPR
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pittsburgh, PA
- Statement
- APPROVAL FOR AN ALTERNATE SUPPLIER OF AN OFF-THE-SHELF SDRAM INTEGRATED CIRCUIT (IC) USED ON THE LIFEVEST® WEARABLE DEFIBRILLATOR MODEL WCD 4000 COMPUTER PRINTED CIRCUIT BOARD ASSEMBLIES (PCA). THE ALTERNATE SUPPLIER IS INTEGRATED SILICON SOLUTIONS INC. (ISSI). THEDEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LIFEVEST WEARABLE DEFIBRILLATOR 4000 AND IS INDICATED FOR ADULT PATIENTS WHO ARE AT RISK FOR SUDDEN CARDIAC ARREST AND ARE NOT CANDIDATES FOR OR REFUSE AN IMPLANTABLE DEFIBRILL
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