MARGINPROBE SYSTEM
FDA premarket approval P110014/S005 · decided 2015-05-18
Approval details
- PMA number
- P110014
- Supplement
- S005
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MARGINPROBE SYSTEM
- Generic name
- Diagnostic low electric field
- Applicant
- Dilon Medical Technologies, Ltd.
- Date received
- 2015-04-15
- Decision date
- 2015-05-18
- Days to decision
- 33 days
- Decision code
- OK30
- Product code
- OEE
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Business Park-South 3088900
- Statement
- TWO CHANGES TO THE CALIBRATION PROBE CONTROL (CPC) AND SENSOR SUB-ASSEMBLIES IN THE MARGINPROBE SYSTEM
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.