|
Device | LIFEVEST WEARABLE DEFIBRILLATOR |
Generic Name | Wearable automated external defibrillator |
Applicant | ZOLL MANUFACTURING CORPORATION 121 GAMMA DR PITTSBURGH, PA 15238-0000 |
PMA Number | P010030 |
Supplement Number | S051 |
Date Received | 05/12/2014 |
Decision Date | 07/14/2014 |
Product Code |
MVK |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A SOFTWARE CHANGE THAT WILL ENABLE ANANALOG CLIPPING NOISE DETECTOR WHICH WILL ALLOW THE SYSTEM TO BETTER RECOGNIZE WHEN AN INPUT SIGNAL MAY BE COMPROMISED DUE TO SATURATION OF ANALOG AMPLIFIERS IN THE ECG SIGNAL PROCESSING CIRCUITRY. |