NOVO TTF-100A SYSTEM
FDA premarket approval P100034/S008 · decided 2014-07-24
Approval details
- PMA number
- P100034
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NOVO TTF-100A SYSTEM
- Generic name
- Stimulator, low electric field, tumor treatment
- Applicant
- Novocure, GmbH
- Date received
- 2014-01-24
- Decision date
- 2014-07-24
- Days to decision
- 181 days
- Decision code
- APPR
- Product code
- NZK
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Baar
- Statement
- APPROVAL TO REPLACE THE CURRENT TYVEK POUCH PACKAGING MATERIAL FOR THE INE TRANSDUCER ARRAYS WITH AN ALUMINUM FOIL MOISTURE BARRIER AND TO EXTEND THE SHELF LIFE FOR THESE TRANSDUCER ARRAYS FROM 6 TO 9 MONTHS.
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