Emerson 1C31227G01 OVATION Westinghouse PLC module
The iX Abdominal Stent Transplant System incorporates the following design improvements over the currently approved Ovation abdominal stent transplant system:
1. The currently approved Ovation Prime aortic body stent is implanted into an improved aortic body delivery catheter with a complete catheter sheath, integrated cross cavity and longer delivery system working length.
2. Currently approved Ovation Prime and/or Ovation iX iliac limb/iliac crest extension stent grafts.
The currently approved CustomSeal kit reduces the curing time of the filled polymer by slightly modifying the proportion of components in the filled polymer kit (reduced detail time: 14 minutes vs.20 minutes). These modifications are based on Ovation user feedback and maintain the basic design and technical features of the Emerson 1C31227G01 OVATION Westinghouse PLC module platform.
The design modification has passed the test verification. Based on the similarities and non-clinical trials between the Emerson 1C31227G01 OVATION Westinghouse PLC Module iX abdominal Stent Transplant system and the Emerson 1C31227G01 OVATION Westinghouse PLC Module Abdominal Stent transplant system, The clinical data obtained from the clinical study on the Ovation iX abdominal stent transplant system are also applicable to the Ovation iX abdominal stent transplant system.
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