- Device
- MarginProbe System
- Applicant
- Dilon Medical Technologies, Ltd.
- PMA number
- P110014
- Supplement
- S008
- Product code
- OEE
- Generic name
- Diagnostic low electric field
- Decision date
- 2019-06-19
- Decision code
- OK30
- Date received
- 2019-05-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New sterilization chamber (No. 8) that has been installed and validated at the Company’s approved contract sterilizer, Mediplast Isreal, Ltd. (Tel Aviv Israel, FDA Registration Number 3008729892).