DUNE MEDICAL DEVICES MARGINPROBE SYSTEM
FDA premarket approval P110014/S007 · decided 2016-03-30
Approval details
- PMA number
- P110014
- Supplement
- S007
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DUNE MEDICAL DEVICES MARGINPROBE SYSTEM
- Generic name
- Diagnostic low electric field
- Applicant
- Dilon Medical Technologies, Ltd.
- Date received
- 2016-03-07
- Decision date
- 2016-03-30
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- OEE
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Business Park-South 3088900
- Statement
- Software (Seal Test station production software) used in the production of the Margin Probe component of the system was updated to alter the sequence in which a folder name is assigned to an electronic folder containing data from the Seal Test.
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