|
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 | S032 |
Date Received | 05/14/2012 |
Decision Date | 07/13/2012 |
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 2 MECHANICAL DESIGN MODIFICATIONS TO THE METHOD OF ATTACHING THE HOOK COMPONENT OF THE HOOK AND LOOP FASTENERS TO THE ECG ELECTRODE HOUSING. |