PMA P100034S011

Device
NOVA TTF-100A SYSTEM
Applicant
Novocure, GmbH
PMA number
P100034
Supplement
S011
Product code
NZK
Decision date
2015-03-17
Classification
Stimulator, Low Electric Field, Tumor Treatment
Generic name
Stimulator, low electric field, tumor treatment
Approval order statement
APPROVAL FOR AN ADDITIONAL MATERIAL SUPPLIER.

Current openFDA PMA Record#

Device
NOVA TTF-100A SYSTEM
Applicant
Novocure, GmbH
PMA number
P100034
Supplement
S011
Product code
NZK
Generic name
Stimulator, low electric field, tumor treatment
Decision date
2015-03-17
Decision code
APPR
Date received
2014-09-24
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR AN ADDITIONAL MATERIAL SUPPLIER.