|
Device | WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST |
Generic Name | Wearable automated external defibrillator |
Applicant | ZOLL MANUFACTURING CORPORATION 121 GAMMA DR PITTSBURGH, PA 15238-0000 |
PMA Number | P010030 |
Supplement Number | S073 |
Date Received | 03/16/2016 |
Decision Date | 06/14/2016 |
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 modifications to current software (bug fixes, improvements, background noise detection feature). |