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mr_sano

01/14/11 11:22 AM

#35391 RE: IMGG4TP #35390

What I don't get is that original we all thought the predicate was GE lightspeed CT/ But if you examine the lateral patient issue in the NSE letter Dean mentions a removable section of the predicate (ALA BREAKAWAY MEDTRONIC DEVICE) SO is the predicate the O arm Breakaway from Medtronic?

<Lateral Patient Access: Deficiency 7 of our January 5 2010 letter expressed concern about the lack of lateral patient access when using your device as opposed to the predicate device. In response, you reiterated a previous argument that opening feature "creates a sense of false security as this opening if inoperable or malfunctioned would allow the...>
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adrian taylor

01/14/11 11:23 AM

#35392 RE: IMGG4TP #35390

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