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. |
|
Device | NOVOTTF-100A SYSTEM |
Generic Name | Stimulator, low electric field, tumor treatment |
Applicant | Novocure GmbH Park 6 CH-6039 Root D4 |
PMA Number | P100034 |
Supplement Number | S004 |
Date Received | 04/08/2013 |
Decision Date | 08/08/2013 |
Product Code |
NZK |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR TRANSFERRING THE RESPONSIBILITY OF PERFORMING THE NOVOTAL TRANSDUCER ARRAY MAPPING FROM NOVOCURES STAFF TO TRAINED PHYSICIANS RESPONSIBLE FOR PRESCRIBING THE DEVICE. |
|
|