PMA P110014S012
- Device
- MarginProbe System
- Applicant
- Dilon Medical Technologies, Ltd.
- PMA number
- P110014
- Supplement
- S012
- Product code
- OEE
- Decision date
- 2022-04-06
- Generic name
- Diagnostic low electric field
- Approval order statement
- Approval for labeling changes including post-approval study clinical data
Current openFDA PMA Record#
- Device
- MarginProbe System
- Applicant
- Dilon Medical Technologies, Ltd.
- PMA number
- P110014
- Supplement
- S012
- Product code
- OEE
- Generic name
- Diagnostic low electric field
- Decision date
- 2022-04-06
- Decision code
- APPR
- Date received
- 2021-10-14
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for labeling changes including post-approval study clinical data