Merit Medical Systems, Inc. (NASDAQ:MMSI) Files An 8-K Regulation FD Disclosure

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Merit Medical Systems, Inc. (NASDAQ:MMSI) Files An 8-K Regulation FD Disclosure

Item 7.01. Regulation FD Disclosure.

On June 22, 2017, Merit Medical Systems, Inc. (the “Company”)
issued a press release announcing that it has received 513(f)(2)
(de novo) classification from the U.S. Food Drug Administration to
expand the indication of the Company’s Embosphere >Microspheres
to include prostatic artery embolization for symptomatic benign
prostatic hyperplasia.
The information in this Current Report on Form 8-K (including the
exhibit attached hereto) is intended to be furnished and shall not
be deemed “filed” for purposes of Section 18 of the Securities
Exchange Act of 1934, as amended (the “Exchange Act”), or
otherwise subject to the liabilities of that section, nor shall it
be deemed incorporated by reference in any filing made by the
Company under the Securities Act of 1933, as amended, or the
Exchange Act, except as expressly set forth by specific reference
in such a filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
99.1
Press Release, dated June 22, 2017, entitled “Merit
Medical’s Embosphere Microspheres Receive FDA
513(f)(2) (de novo) Classification for Prostatic Artery
Embolization Indication”.



MERIT MEDICAL SYSTEMS INC Exhibit
EX-99.1 2 a06222017-8kpressreleaseex.htm EXHIBIT 99.1 Exhibit  Exhibit 99.1FOR IMMEDIATE RELEASEDate:June 22,…
To view the full exhibit click here
About Merit Medical Systems, Inc. (NASDAQ:MMSI)

Merit Medical Systems, Inc. is a designer, developer, manufacturer and marketer of medical devices used in an array of interventional and diagnostic procedures. The Company operates in two segments: cardiovascular and endoscopy. Its cardiovascular segment consists of cardiology and radiology devices, which assist in diagnosing and treating coronary arterial disease, peripheral vascular disease and other non-vascular diseases; embolotherapeutic products, and cardiac rhythm management and electrophysiology (CRM/EP) devices. Its endoscopy segment consists of gastroenterology and pulmonology medical devices, which assist in the palliative treatment of expanding esophageal, tracheobronchial and biliary strictures caused by malignant tumors. Its products are used in various clinical areas, such as diagnostic and interventional cardiology; interventional radiology; vascular, general and thoracic surgery; interventional pulmonology; interventional nephrology; oncology, and pain management.