DDL added testing of catheters, luers, needles, syringes, guidewires, and IV infusion sets at its laboratory located in Irvine, California. Previously, testing of these products was only available at DDL’s headquarters in Eden Prairie, Minnesota.
The DDL West recently relocated from Fountain Valley to Irvine, more than doubling lab space and increasing testing capacity. The medical device testing being added is in addition to the package testing (ISO 11607) and ICH stability testing already offered in the facility.
US FDA approvals
Surmodics Inc., 510(k) clearance for 0.018” Low-Profile percutaneous transluminal angioplasty (PTA) balloon dilation catheter. It combines advanced balloon technologies with Surmodics’ low-friction, low-particulate Serene hydrophilic coating for tracking and lesion-crossing performance while delivering high pressures, ranging from 2mm to 10mm in diameter.
Arthrosurface, clearance of the OVOMotion shoulder arthroplasty system, a stemless total shoulder system that allows surgeons to increase exposure to the glenoid and minimize bone removal for patients with painful and/or severely disabled shoulder joints. Clearance allows for use in conjunction with Arthrosurface’s inlay glenoid system.
Abbott, clearance of Advisor HD Grid Mapping Catheter, Sensor Enabled, offers physicians a grid configuration that captures critical information for creation of high-density maps of cardiac tissue to support optimal treatment for patients. Physicians can see electrical signals that they may have missed using standard mapping catheters.
Nextremity Solutions, FDA 510(k) for Lapidus Procedure System, a three-part construct intended for internal fixation for first metatarsocuneiform arthrodesis (also known as lapidus or first tarsometatarsal fusion). An application for a CE mark is pending.
Med-El USA, clearance for ADHEAR, non-surgical bone conduction hearing technology for conductive hearing loss. ADHEAR stays in position without applying pressure onto the skin.