MARGINPROBE SYSTEM

Diagnostic Low Electric Field

FDA Premarket Approval P110014 S005

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Two changes to the calibration probe control (cpc) and sensor sub-assemblies in the marginprobe system

DeviceMARGINPROBE SYSTEM
Classification NameDiagnostic Low Electric Field
Generic NameDiagnostic Low Electric Field
ApplicantDUNE MEDICAL DEVICES INC
Date Received2015-04-15
Decision Date2015-05-18
PMAP110014
SupplementS005
Product CodeOEE
Advisory CommitteeGeneral & Plastic Surgery
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address DUNE MEDICAL DEVICES INC 111 Speen St Suite 101 framingham, MA 01701

Supplemental Filings

Supplement NumberDateSupplement Type
P110014Original Filing
S012 2021-10-14 Normal 180 Day Track No User Fee
S011 2020-07-28 30-day Notice
S010 2019-10-07 Normal 180 Day Track No User Fee
S009 2019-08-29 Normal 180 Day Track No User Fee
S008 2019-05-21 30-day Notice
S007 2016-03-07 30-day Notice
S006 2015-07-06 Real-time Process
S005 2015-04-15 30-day Notice
S004 2014-09-23 30-day Notice
S003 2014-04-15 Normal 180 Day Track
S002 2014-01-28 Normal 180 Day Track No User Fee
S001 2013-01-25 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
07290012534010 P110014 000
07290012534034 P110014 000
07290012534058 P110014 000

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