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PAVmed down 18% on extended review timeline for CarpX device

Aug. 23, 2018 9:59 AM ETPAVmed Inc. (PAVM) StockPAVMBy: Douglas W. House, SA News Editor
  • Nano cap PAVmed (PAVM -18.1%) is down on increased volume in response to its disclosure that it will resubmit its U.S. application seeking clearance for its CarpX device for the treatment of carpal tunnel syndrome.
  • It previously filed a 510(k) application using a commercially available carpal tunnel release device as a predicate (comparator). The FDA notified the company yesterday that the review team had failed to reach a consensus on the filing within the standard timeframe and recommended that it extend the review period with a resubmission (initiated today). It expects to complete the process in 30- 45 days. If rejected again, an appeal is likely.

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