OPTUNE
FDA premarket approval P100034/S010 · decided 2014-09-28
Approval details
- PMA number
- P100034
- Supplement
- S010
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- OPTUNE
- Generic name
- Stimulator, low electric field, tumor treatment
- Applicant
- Novocure, GmbH
- Date received
- 2014-05-30
- Decision date
- 2014-09-28
- Days to decision
- 121 days
- Decision code
- APPR
- Product code
- NZK
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Baar
- Statement
- APPROVAL FOR A TRADE NAME CHANGE FROM THE NOVOTTF-100A SYSTEM TO OPTUNE¿. YOU HAVE ALSO REQUESTED THAT THE COMPONENTS OF THE NOVOTTF-100A SYSTEM (A PLUGIN POWER SUPPLY; CHARGER FOR PORTABLE BATTERIES; DEVICE & BATTERY CARRYING BAG; PORTABLE BATTERY; AND, CONNECTION CABLE & BOX), ALONG WITH THE TRANSDUCER ARRAY AND ELECTRIC FIELD GENERATOR (THE DEVICE), BE NAMED THE OPTUNE¿ TREATMENT KIT.
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