PAVmed Successfully Completes Clinical Safety Study Procedures for CarpX™ 510(k) Re-submission
PAVmed Inc. (PAVM)
US:NASDAQ Investor Relations:
ir.pavm.com
Company Research
Source: GlobeNewswire
All 20 patients underwent successful CarpX procedures while passing primary effectiveness endpoint, with all follow-up patients to date passing primary safety endpoint CarpX™ NEW YORK, Aug. 15, 2019 (GLOBE NEWSWIRE) -- PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company” or “PAVmed”), a highly differentiated, multiproduct medical device company, today announced that all 20 patients of its first-in-human (FIH) 510(k) clinical safety study underwent successful CarpX procedures. The study is being conducted to support PAVmed’s planned 510(k) re-submission to the U.S. Food and Drug Administration (FDA) seeking marketing clearance of its CarpX minimally invasive carpal tunnel release device. “We are excited to have achieved this critical milestone,” said Lishan Aklog, M.D., PAVmed’s Chairman and Chi
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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