BEUDAMED
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    Medtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size and a catheter. Product Usage: The implantable Model 8637 SynchroMed II programmable pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a Model 8637 SynchroMed II pump, supplied in 20 ml and 40 ml reservoir sizes, and a catheter. In the United States, the SynchroMed II Pump is specifically approved (indicated) for drugs as referenced in Indications Drug Stability and Emergency Procedures Reference Manual (refer to attached labeling # MA08927A006).

    FDA Enforcement
    Class II ·Ongoing·Medtronic Neuromodulation·March 14, 2018

    SynchroMed II Infusion Pump. Product Number: 8637-20

    FDA Enforcement
    Class II ·Ongoing·Medtronic Neuromodulation·October 30, 2024

    Medtronic SynchroMed II, Model 8637-20, Programmable pump

    FDA Enforcement
    Class II ·Ongoing·Medtronic Neuromodulation·January 3, 2024

    Medtronic SynchroMed¿ II Implantable Drug Infusion Pump, Model 8637-20, 8637-40. The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a SynchroMed II pump and a catheter.

    FDA Enforcement
    Class II ·Terminated·Medtronic Neuromodulation·May 14, 2014

    Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40. Sterile. Product Usage: The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a SynchroMed II pump and a catheter

    FDA Enforcement
    Class II ·Terminated·Medtronic Neuromodulation·June 3, 2015

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020