|
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 | S044 |
Date Received | 09/03/2013 |
Decision Date | 10/03/2013 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement FOUR MANUFACTURING CHANGES RELATED TO THE LIFEVEST 4000 AUTO TEST FIXTUREUSED TO AUTOMATE THE FUNCTIONALITY TESTING OF THE DEVICE. |