PAVmed Announces FDA 510(k) Re-submission for its CarpX™ Minimally Invasive Carpal Tunnel Device
PAVmed Inc. (PAVM)
US:NASDAQ Investor Relations:
ir.pavm.com
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Source: GlobeNewswire
Incorporates data from successful clinical safety study in which all patients met pre-specified safety and effectiveness endpoints NEW YORK, March 09, 2020 (GLOBE NEWSWIRE) -- PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company” or “PAVmed”), a highly differentiated, multiproduct medical device company, today announced the U.S. Food and Drug Administration (FDA) has acknowledged receipt of a 510(k) premarket notification submission for the Company’s CarpX™ minimally invasive carpal tunnel device. This re-submission incorporates data from the Company’s successful first-in-human CarpX clinical safety study, in which all patients met the study’s pre-specified safety and effectiveness endpoints. “We look forward to completing the U.S. regulatory process for CarpX so we can begin offering this groundbreaking technology for alleviating carpal tunnel syndrome to physicians and their patients,” said Lishan Aklog, M.D., PAVmed’s Chairman and Chief Executive Officer. “We believe the data in thi
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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