Attached files
| file | filename |
|---|---|
| EX-99.1 - EX-99.1 - NEVRO CORP | d857679dex991.htm |
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 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): January 22, 2015
NEVRO CORP.
(Exact name of registrant as specified in its charter)
| Delaware | 001-36715 | 56-2568057 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification Number) |
4040 Campbell Avenue
Menlo Park, CA 94025
(Address of principal executive offices, including Zip Code)
Registrant’s telephone number, including area code: (650) 251-0005
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:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| Item 8.01 | Other Events. |
On January 22, 2015, Nevro Corp. (the “Company”) announced that it has received a letter from the U.S. Food and Drug Administration informing the Company of the approvability of its Premarket Approval Application (“PMA”) for the Senza® spinal cord stimulation system. According to the approvable letter, approval of the PMA is subject to satisfaction of regulatory inspections and audits of manufacturing facilities, methods and controls for Senza to ensure compliance with the FDA’s Quality System Regulation, as well as finalization of the product’s labeling with the FDA.
A copy of the press release is attached hereto as Exhibit 99.1 and incorporated by reference herein.
| Item 9.01 | Financial Statements and Exhibits. |
Reference is made to the Exhibit Index attached hereto.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| NEVRO CORP. | ||||||
| Date: January 22, 2015 | By: | /s/ Andrew H. Galligan | ||||
| Andrew H. Galligan | ||||||
| Chief Financial Officer | ||||||
EXHIBIT INDEX
| Exhibit No. |
Description | |
| 99.1 | Press release dated January 22, 2015. | |