PMA P110014S009
- Device
- MarginProbe System
- Applicant
- Dilon Medical Technologies, Ltd.
- PMA number
- P110014
- Supplement
- S009
- Product code
- OEE
- Decision date
- 2019-09-20
- Classification
- Diagnostic Low Electric Field
- Generic name
- Diagnostic low electric field
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- MarginProbe System
- Applicant
- Dilon Medical Technologies, Ltd.
- PMA number
- P110014
- Supplement
- S009
- Product code
- OEE
- Generic name
- Diagnostic low electric field
- Decision date
- 2019-09-20
- Decision code
- APPR
- Date received
- 2019-08-29
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.