NOVOTTF-100A SYSTEM
FDA premarket approval P100034/S002 · decided 2012-12-03
Approval details
- PMA number
- P100034
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NOVOTTF-100A SYSTEM
- Generic name
- Stimulator, low electric field, tumor treatment
- Applicant
- Novocure, GmbH
- Date received
- 2012-09-28
- Decision date
- 2012-12-03
- Days to decision
- 66 days
- Decision code
- APPR
- Product code
- NZK
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Baar
- Statement
- APPROVAL FOR MODIFICATION TO THE FIELD GENERATOR COMPONENT OF THENOVOTTF-L00A SYSTEM TO REPLACE PIN: DAC7614E WITH PIN: 2IC-103572, AND CORRESPONDING CHANGES TO THE ASSOCIATED RESISTORS AND CAPACITORS TO LIMIT THE PART VOLTAGE RANGE AND ELIMINATE AN OBSERVED CURRENT SPIKE. CORRESPONDING SOFTWARE CHANGES WERE ALSO MADE TO REFLECT THESEMODIFICATIONS.
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