PMA P110014S007

Device: DUNE MEDICAL DEVICES MARGINPROBE SYSTEM
Applicant: Dilon Medical Technologies, Ltd.
PMA number: P110014
Supplement: S007
Product code: OEE
Decision date: 2016-03-30
Classification: Diagnostic Low Electric Field
Generic name: Diagnostic low electric field
Approval order 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.

Current openFDA PMA Record#

Device: DUNE MEDICAL DEVICES MARGINPROBE SYSTEM
Applicant: Dilon Medical Technologies, Ltd.
PMA number: P110014
Supplement: S007
Product code: OEE
Generic name: Diagnostic low electric field
Decision date: 2016-03-30
Decision code: OK30
Date received: 2016-03-07
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order 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.