PMA P100034S008
- Device
- NOVO TTF-100A SYSTEM
- Applicant
- Novocure, GmbH
- PMA number
- P100034
- Supplement
- S008
- Product code
- NZK
- Decision date
- 2014-07-24
- Classification
- Stimulator, Low Electric Field, Tumor Treatment
- Generic name
- Stimulator, low electric field, tumor treatment
- Approval order 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.
Current openFDA PMA Record#
- Device
- NOVO TTF-100A SYSTEM
- Applicant
- Novocure, GmbH
- PMA number
- P100034
- Supplement
- S008
- Product code
- NZK
- Generic name
- Stimulator, low electric field, tumor treatment
- Decision date
- 2014-07-24
- Decision code
- APPR
- Date received
- 2014-01-24
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.