|
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 | S019 |
Date Received | 12/28/2009 |
Decision Date | 05/21/2010 |
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 COMPONENT VALUE CHANGE TO THE ECG ELECTRODE BUFFER BOARDS TO IMPROVE ECG AMPLIFIER COMMON MODE REJECTION. |