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Ovation 5X00482G02 Module New In Box_Good DCS
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Ovation 5X00482G02 Module New In Box

  • Brand: Ovation
  • Model Number: 5X00482G02
  • Origin: USA
  • Condition: New 100%
  • Payment Methods: T/T, PayPal, Western Union
  • Warranty: 1 Year
  • Lead Time: 1-3 Working Days
  • Courier partners: DHL, UPS, TNT, FedEx and EMS.
  • Business hours: 7*24
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Ovation 5X00482G02

Brand New Ovation 5X00482G02 ModuleOne year warranty


Description

The objective of the Ovation Abdominal Stent Graft System multicenter clinical study was to evaluate the safety and effectiveness of the Ovation Abdominal Stent Graft System in the treatment of subjects with AAA. The study was a prospective, consecutively enrolling, non-randomized multi-center clinical evaluation. A total of 161 subjects were enrolled in the pivotal study in the United States (111 subjects), Germany (30 subjects) and Chile (20 subjects). The sample size of the study was calculated based upon the primary safety evaluation. It was estimated that 150 subjects with evaluable data at 30 days would provide 96% statistical power to test the primary safety hypothesis (major adverse event [MAE] incidence of 11%) at the one-sided 0.05 level. A 15% attrition rate was anticipated through 12 months, which would yield approximately 128 subjects available to assess the primary effectiveness endpoint at 12 months. Should the rate for the primary effectiveness composite endpoint equal 88.2%, then 128 subjects would provide 80% power to test the primary effectiveness hypothesis at the onesided 0.05 alpha level. The sample size of the study provided adequate statistical power for the evaluation of safety and effectiveness. The analysis included endpoints that were consistent with current literature on endovascular stent grafts. The primary safety hypothesis was tested by comparing the 30-day major adverse event (MAE) incidence in subjects treated with the Ovation device to a target performance goal of 21%1. The primary effectiveness hypothesis was tested by comparing the 12-month composite treatment success rate in subjects treated with the Ovation device to a target performance goal of 80%. For effectiveness endpoint evaluation, an independent core lab reviewed CT scans and abdominal x-rays to assess aneurysm changes, device position and integrity, and endoleaks


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FAQ:

1.Is the part new?
Yes, 100% Original brand new
2.How is the package?
Original factory seal packed
3.What is the lead time?
In stock: 1-3 working days
4.What is the MOQ:
1pcs
5.What is the payment term:
TT and Western Union, other negotiable
6.Where the item ship from?
Xiamen
7.What is the warranty time?
One year

8. How to delivery the PLC Parts?
Kindly tell us your address,we check best cost for you
Or you can use your own courier account or agent, DHL, FEDEX, UPS etc are available.

About Us

for many years, is a professional engaged in large-scale system (distributed control system, programmable controller, redundant fault-tolerant control systems, robot control system, large servo control system is the central feeding system plastic molding auxiliary equipment and automation of whole plant planning) imported automation system such as spare parts, modules, sales and system integration of high-tech enterprises. The company is equipped with professional technicians to provide customers with better service.


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We have tens of thousands of models and tens of thousands of stocks in stock, welcome to consult!

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Company Information
Email sales@bodadcs.com
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Whatsapp +8613666084105
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Add Room 1004, No. 62, Xiangxiuli, Siming District, Xiamen City, Fujian Province, China


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