|
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 | S048 |
Date Received | 01/22/2014 |
Decision Date | 02/21/2014 |
Product Code |
MVK |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement IMPLEMENTATION OF THE IN CIRCUIT TEST (ICT) FIXTURE FOR ELECTRICAL TESTING OF THE PRINTED CIRCUIT ASSEMBLY (PCA) OF THE LIFEVEST 4000 BATTERY CHARGER/ MODEM¿S BEDSIDE PCA. |