|
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 | S058 |
Date Received | 11/13/2014 |
Decision Date | 02/22/2015 |
Product Code |
MVK |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR 1) ADDING A NEW SECTION TO THE PATIENT MANUAL THAT ADDRESSES `ENVIRONMENTAL CONSIDERATIONS RELATED TO NOISE AND VIBRATION; 2) ADDING A NEW SECTION TO THE OPERATOR MANUAL THAT ADDRESSES `PHYSICIAN INFORMATION TO INSTRUCT PATIENT CAREGIVERS; AND 3) ADDING A NEW SECTION TO THE PATIENT MANUAL THAT ADDRESSES `WHAT FAMILY MEMBERS NEED TO KNOW. |