|
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 | S034 |
Date Received | 05/29/2012 |
Decision Date | 07/25/2012 |
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 A CHANGE OF PLATING MATERIAL FROM TIN TO GOLD ON THE FOLLOWING COMPONENTS: 1) BOARD-TO-BOARD CONNECTORS ON THE COMPUTER BOARD AND HIGH VOLTAGE BOARD; 2) 12-POSITION JUMPER; AND 3) BOARD-TO-BOARD CONNECTORS ON THE COMPUTER, BEDSIDE, AND BATTERY CONNECTOR BOARDS. |