PMA P100034S009
- Device
- NOVOTTF-100A TREATMENT KIT
- Applicant
- Novocure, GmbH
- PMA number
- P100034
- Supplement
- S009
- Product code
- NZK
- Decision date
- 2014-07-25
- 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 FORTHE 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
- NOVOTTF-100A TREATMENT KIT
- Applicant
- Novocure, GmbH
- PMA number
- P100034
- Supplement
- S009
- Product code
- NZK
- Generic name
- Stimulator, low electric field, tumor treatment
- Decision date
- 2014-07-25
- Decision code
- APPR
- Date received
- 2014-03-20
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL TO REPLACE THE CURRENT TYVEK POUCH PACKAGING MATERIAL FORTHE INE TRANSDUCER ARRAYS WITH AN ALUMINUM FOIL MOISTURE BARRIER AND TO EXTEND THE SHELF LIFE FOR THESE TRANSDUCER ARRAYS FROM 6 TO 9 MONTHS.