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  • 1.  PTA catheter guidance

    Posted 02-Sep-2015 10:52
    Hi everyone, 

    I've scoured the FDA's website looking for a percutaneous transluminal angioplasty (PTA) catheter guidance document, but so far have only found one related to PTCA for coronary angioplasty balloon catheters. Am I missing something and is there a PTA catheter-specific guidance/draft guidance?

    Thanks,

    Mark


  • 2.  RE: PTA catheter guidance

    Posted 02-Sep-2015 12:03
    Mark,

    The said guidance is believed to span the PTA.

    Recently the first drug coated baloon PTA was approved (https://www.globalcomplianceseminar.com/?attachment_id=6742). 

    s/ David
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