|
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 | S015 |
Date Received | 10/30/2009 |
Decision Date | 12/16/2009 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL OF AN ALTERNATE FLASH/SRAM CHIP FOR USE ON THE WCD 3100, A CORRECTION OF A BILL OF MATERIALS ERROR ON THE WCD 3100 COMPUTER/ANALOG PRINTED CIRCUIT ASSEMBLY, AND TWO DESIGN CHANGES TO THE HIGH VOLTAGE CONVERTER CIRCUIT ON THE DEFIBRILLATOR PRINTED CIRCUIT ASSEMBLY. |