MarginProbe System
FDA premarket approval P110014/S008 · decided 2019-06-19
Approval details
- PMA number
- P110014
- Supplement
- S008
- 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
- 2019-05-21
- Decision date
- 2019-06-19
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- OEE
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Business Park-South 3088900
- Statement
- New sterilization chamber (No. 8) that has been installed and validated at the Companys approved contract sterilizer, Mediplast Isreal, Ltd. (Tel Aviv Israel, FDA Registration Number 3008729892).
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.