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Premarket Approval (PMA) - Food and Drug Administration

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?id=P110014
    DUNE MEDICAL DEVICES MARGINPROBE SYSTEM: Generic Name: diagnostic low electric field: Applicant: Dilon Medical Technologies, Ltd. 20 alon hatavor …

FDA Formally Accepts Dune Medical's MarginProbe™ …

    https://www.prnewswire.com/news-releases/fda-formally-accepts-dune-medicals-marginprobe-system-pre-market-approval-pma-application-and-grants-expedited-review-status-121891273.html
    It is an investigational device in the United States. About Dune Medical Devices Dune Medical Devices is a private medical device company developing …

Dune Medical Devices Receives Approvable Letter from …

    https://www.prnewswire.com/news-releases/dune-medical-devices-receives-approvable-letter-from-fda-for-the-marginprobe-system-179936361.html
    Dune Medical Devices is a privately held company financed by Apax Partners since 2004. It has offices in the U.S., Israel, Germany and Switzerland. Contact: …

Dune Medical Devices Receives FDA Approval for …

    https://www.mddionline.com/news/dune-medical-devices-receives-fda-approval-breakthrough-cancer-detector
    Today, FDA granted PMA approval to the MarginProbe System created by Dune Medical Devices Inc. MarginProbe is based on a proprietary technology created by …

Premarket Approval (PMA) - Food and Drug Administration

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?start_search=1&SupplementType=NONE
    Premarket Approval (PMA) Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics …

FDA issues approvable letter to Dune Medical PMA for breast …

    https://www.medicaldevice-network.com/uncategorized/newsfda-issues-approvable-letter-to-dune-medical-pma-for-breast-cancer-detection-system/
    The US Food and Drug Administration (FDA) has issued an approvable letter for Dune Medical Devices ‘ premarket approval application ( PMA) for its MarginProbe …

FDA issues approvable letter to Dune Medical PMA for breast …

    https://www.medicaldevice-network.com/uncategorised/newsfda-issues-approvable-letter-to-dune-medical-pma-for-breast-cancer-detection-system/
    Medical Devices. Anesthesia and Respiratory Devices; Cardiovascular; Dental Devices; Diabetes Care Devices; Nephrology and Urology Devices; Neurology …

Dune Medical Plans Summer Submission For Breast Cancer …

    https://medtech.pharmaintelligence.informa.com/MT028814/Dune-Medical-Plans-Summer-Submission-For-Breast-Cancer-Probe-PMA
    Dune Medical will submit a PMA application this summer for its MarginProbe intraoperative real-time margin detection system for breast cancer surgery, according to …

Dune Medical Devices Receives FDA Approval for Breakthrough …

    https://www.fdanews.com/articles/152074-dune-medical-devices-receives-fda-approval-for-breakthrough-advancement-in-breast-cancer-surgery
    Dune Medical Devices Receives FDA Approval for Breakthrough Advancement in Breast Cancer Surgery January 3, 2013 Dune Medical Devices …

Dune Medical Gets PMA for Breast Cancer Surgery Probe

    http://www.bioisrael.com/dune-medical-gets-pma-for-breast-cancer-surgery-probe
    Dune Medical Devices was founded in 2002 by Dr. Dan Hashimshony to realize the extraordinary medical potential of its proprietary tissue characterization …



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