UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 8-K

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): August 22, 2018

Registrant’s telephone number, including area code: (212) 949-4319

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company [X]

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [  ]

Item 7.01. Regulation FD Disclosure.

As previously disclosed, on November 27, 2017, PAVmed Inc. (the “Company”) filed a 510(k) premarket notification submission with the Federal Food and Drug Administration (“FDA”) for the Company’s CarpX™ product, using a commercially available carpal tunnel release device as a predicate. On August 22, 2018, the Company was notified by the lead FDA branch reviewing the submission that it had not reached a consensus with the consulting FDA branch within the review period allotted under the FDA’s rules and regulations. Accordingly, the lead branch recommended to the Company that it take the appropriate steps to extend the review process through a resubmission, which it initiated today. The Company plans to remain closely engaged with the lead branch reviewer in preparation for a pre-submission meeting which the Company hopes to secure in the next 30 to 45 days. The Company also will engage FDA counsel to assist with the process and any appeals.

The information furnished under this Item 7.01 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, nor shall it be deemed incorporated by reference in any disclosure document of the Company, except as shall be expressly set forth by specific reference in such document.

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.