Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 3000, 3100, 4000. |
Generic Name | Wearable automated external defibrillator |
Applicant | ZOLL MANUFACTURING CORPORATION 121 GAMMA DR PITTSBURGH, PA 15238-0000 |
PMA Number | P010030 |
Supplement Number | S086 |
Date Received | 10/27/2016 |
Decision Date | 04/25/2017 |
Product Code |
MVK |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval to modify the Zoll Wearable Cardioverter Defibrillator (WCD) 3000, 3100, and 4000 Operators Manuals to reflect the results of the Post-Approval Study. |
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