PMA P100034S014
- Device
- NOVOCURE'S OPTUNE SYSTEM
- Applicant
- Novocure, GmbH
- PMA number
- P100034
- Supplement
- S014
- Product code
- NZK
- Decision date
- 2016-02-09
- Classification
- Stimulator, Low Electric Field, Tumor Treatment
- Generic name
- Stimulator, low electric field, tumor treatment
- Approval order statement
- Approval of the following changes to the post-approval study for the device: modification to enrollment criteria.
Current openFDA PMA Record#
- Device
- NOVOCURE'S OPTUNE SYSTEM
- Applicant
- Novocure, GmbH
- PMA number
- P100034
- Supplement
- S014
- Product code
- NZK
- Generic name
- Stimulator, low electric field, tumor treatment
- Decision date
- 2016-02-09
- Decision code
- APPR
- Date received
- 2015-08-21
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- Approval of the following changes to the post-approval study for the device: modification to enrollment criteria.