PAVmed Receives FDA 510(k) Clearance for its CarpX™ Minimally Invasive Carpal Tunnel Device
PAVmed Inc. (PAVM)
US:NASDAQ Investor Relations:
ir.pavm.com
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Source: GlobeNewswire
NEW YORK, April 21, 2020 (GLOBE NEWSWIRE) -- PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company” or “PAVmed”), a highly differentiated, multiproduct medical device company, today announced it has received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) for its CarpX™ minimally invasive carpal tunnel device. PAVmed Inc. The FDA determined that CarpX is “substantially equivalent to legally marketed predicates” and that PAVmed may market CarpX for “the minimally invasive isolation and incision/division of ligaments, tendons, or fascia such as the transverse carpal ligament for treatment of carpal tunnel syndrome.” The FDA reached this determination after reviewing detailed data from the Company’s successful CarpX clinical safety study performed in New Zealand. “
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PAVM
Sec Filings
- 3/25/24 - Form 10-K
- 3/14/24 - Form 8-K
- 3/14/24 - Form 8-K
- PAVM's page on the SEC website