|
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 | S025 |
Date Received | 01/03/2011 |
Decision Date | 06/29/2012 |
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 DESIGN CHANGES TO THE LIFEVEST GARMENT INCLUDING LOCATION OF THE REAR THERAPY PADS AND VIBRATION BOX, METHOD OF SECURING VIBRATION BOX TO GARMENT, ADJUSTMENT MECHANISM FOR SHOULDER STRAP, WIDTH OF ELASTIC STRAP AND RELATED LABELING CHANGES. |