NOVOTTF-100A TREATMENT KIT
FDA premarket approval P100034/S009 · decided 2014-07-25
Approval details
- PMA number
- P100034
- Supplement
- S009
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NOVOTTF-100A TREATMENT KIT
- Generic name
- Stimulator, low electric field, tumor treatment
- Applicant
- Novocure, GmbH
- Date received
- 2014-03-20
- Decision date
- 2014-07-25
- Days to decision
- 127 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 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.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.