|
Device | LIFEVEST DEVICE |
Generic Name | Wearable automated external defibrillator |
Applicant | ZOLL MANUFACTURING CORPORATION 121 GAMMA DR PITTSBURGH, PA 15238-0000 |
PMA Number | P010030 |
Supplement Number | S045 |
Date Received | 11/21/2013 |
Decision Date | 12/20/2013 |
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 ADDITIONAL SPOT WELDER AS WELL AS UPDATES TO INSPECTION INSTRUCTIONS FOR THE LIFEVEST WEARABLE CARDIOVERTER DEFIBRILLATOR. |