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"Jim not only has a good understanding of coatings but one of the best understandings of infection control and antimicrobial technologies of anyone in the business. He has also championed the regulatory strategy and pathway for some groundbreaking FDA submissions. If I ever need expertise or guidance regarding infection control, antimicrobial technologies, combination products, or the regulatory process for such medical devices, Jim is the first person I contact."

~ Margaret 'Peg' Palmer
President/CEO
Surface Solution Labs, Inc.

PRODUCTS
COMMERCIALIZED COMBINATION PRODUCT MEDICAL DEVICES

AMxTek’s Principal – Jim Walls, MS, BioMed, has over 15 years of executive management experience as Vice President of R&D for two major hospital supply/medical device companies, and as Vice President of Business Development for a development-stage orthobiologics company. During his tenure he was responsible for or contributed significantly to the successful commercialization of the following Combination Product Medical Devices:

Product Description Antimicrobial Company 510(K) No.
Kerlix™ AMD Antimicrobial Gauze Polyhexamethylene Biguanide [PHMB] Covidien plc. K990530
Dover® Silver Antimicrobial Foley Catheter Inorganic Silver Polymer
[Ag3PO4]
Covidien, plc. K024010
Agento® I.C. Antimicrobial Endotracheal Tube Silver Salts
Colloidal Suspension
C. R. Bard, Inc. K071365
Elutia Antimicrobial Surgical Wound Drain Silver Sulfadiazine Hydrogel Coating Bacterin International Holdings, Inc. K063245