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    A FONE SURGICO

    FDA registration
    A FONE SURGICO·7 products·🇵🇰 Pakistan

    ArtisanTM 70 cm 2 x 8 Surgical Lead Kit, part number M365SC8216700. 2 x 8 Surgical Paddle Lead Kit: (1) One Paddle Lead (4); Four Suture Sleeves; (2) Lead Position Labels, left and right (Non-Sterile); (1) Device Registration Form/Temporary Patient Identification Card; (1) Manual - Product Usage: The surgical paddle leads function as a component of Boston Scientific s spinal cord stimulator (SCS) systems by delivering electrical stimulation to the nerve structures in the dorsal aspect of the spinal cord, resulting in a inhibition of pain sensation.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Neuromodulation Corporation·June 3, 2020

    ArtisanTM 70 cm 2 x 8 Surgical Lead Kit, part number M365SC8216700. 2 x 8 Surgical Paddle Lead Kit: (1) One Paddle Lead (4); Four Suture Sleeves; (2) Lead Position Labels, left and right (Non-Sterile); (1) Device Registration Form/Temporary Patient Identification Card; (1) Manual - Product Usage: The surgical paddle leads function as a component of Boston Scientific s spinal cord stimulator (SCS) systems by delivering electrical stimulation to the nerve structures in the dorsal aspect of the spinal cord, resulting in a inhibition of pain sensation.

    FDA Recall
    Terminated ·Boston Scientific Neuromodulation Corporation·Product code LGW·April 24, 2019

    TapMed Logistik GmbH

    Importer
    🇩🇪 Germany·11 Manufacturers

    TapMed Medizintechnik Handels GmbH

    Importer
    🇩🇪 Germany·10 Manufacturers

    American Dental Systems GmbH

    Importer
    🇩🇪 Germany·37 Manufacturers

    CMC Medical Devices & Drugs SL

    Authorized representative
    🇪🇸 Spain·698 Manufacturers·11260 Devices