PMA P110014S011
- Device
- MarginProbe System
- Applicant
- Dilon Medical Technologies, Ltd.
- PMA number
- P110014
- Supplement
- S011
- Product code
- OEE
- Decision date
- 2020-08-14
- Generic name
- Diagnostic low electric field
- Approval order statement
- Changes to device and instructions for use labeling reflecting change in ownership and removal of CE mark.
Current openFDA PMA Record#
- Device
- MarginProbe System
- Applicant
- Dilon Medical Technologies, Ltd.
- PMA number
- P110014
- Supplement
- S011
- Product code
- OEE
- Generic name
- Diagnostic low electric field
- Decision date
- 2020-08-14
- Decision code
- OK30
- Date received
- 2020-07-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to device and instructions for use labeling reflecting change in ownership and removal of CE mark.