Outside of US: Chronic infusion of drugs or fluids tested as compatible and listed in the product labeling. PRODUCT ADVISORIES Medtronic has notified physicians about product advisories related to Medtronic Targeted Drug Delivery Systems. Medtronic has limitations on the number of users that can concurrently log in to the Licensed Software at any given time. The SynchroMed™ II programmable, implantable pump delivers drug to the intrathecal space via an implanted catheter. The catheter access port (CAP) allows injection of the drug directly into the implanted catheter for drug administration and diagnostic purposes. Rahway, N.J.-based Wytech was founded in 1975 and manufactures specialty core wires and related components for the interventional medical markets. In 1988, FDA first approved SynchroMed as a Class III medical device for the infusion of drugs to palliatively treat certain types of cancer, pursuant to FDA’s Premarket Approval (PMA) process, the agency’s most stringent medical device review process. The SynchroMed II device was approved in 2003 under the same guidelines. The SynchroMed™ II drug pump is a battery-powered implantable and programable device that stores and dispenses medication inside the body. Legal Compliance. This field is for validation purposes and should be left unchanged. In January, 2018 we announced FDA approval of a new tablet-based clinician programmer to simplify therapy management by providing physicians with visual tools and intuitive workflows. Data is publicly available through our. She alleged the pump failure was caused by manufacturing defects and brought Missouri state law claims for strict liability, negligence and breach of implied warranty of merchantability. 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