UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
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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.):
| 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) |
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Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging growth company
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 8.01. | Other Events. |
The Food and Drug Administration (“FDA”) announced (and made available on the FDA’s website) that, on October 26, 2022, a public advisory committee meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee (the “Committee”) will convene to discuss, among other things, and make recommendations on the classification proposal for tissue expanders and accessories, which are currently unclassified preamendments devices, to be class III (general controls and premarket approval) and class II (general and special controls). If the Committee recommends and, after the comment and review process, reclassifies tissue expanders as Class III devices, it may create additional barriers to entry for future tissue expanders products such as clinical studies and testing and other requirements generally associated with pre-market approval, which may delay approval of our next generation tissue expander.
SIGNATURES
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.
| SIENTRA, INC. | ||||||
| Date: October 20, 2022 | By: | /s/ Ronald Menezes | ||||
| Ronald Menezes | ||||||
| President and Chief Executive Officer | ||||||
Document and Entity Information |
Oct. 20, 2022 |
|---|---|
| Cover [Abstract] | |
| Amendment Flag | false |
| Entity Central Index Key | 0001551693 |
| Document Type | 8-K |
| Document Period End Date | Oct. 20, 2022 |
| Entity Registrant Name | SIENTRA, INC. |
| Entity File Number | 001-36709 |
| Entity Incorporation State Country Code | DE |
| Entity Tax Identification Number | 20-5551000 |
| Entity Address, Address Line One | 420 South Fairview Avenue |
| Entity Address, Address Line Two | Suite 200 |
| Entity Address, City or Town | Santa Barbara |
| Entity Address, State or Province | CA |
| Entity Address, Postal Zip Code | 93117 |
| City Area Code | (805) |
| Local Phone Number | 562-3500 |
| Written Communications | false |
| Soliciting Material | false |
| Pre Commencement Tender Offer | false |
| Pre Commencement Issuer Tender Offer | false |
| Security 12b Title | Common Stock, par value $0.01 per share |
| Trading Symbol | SIEN |
| Security Exchange Name | NASDAQ |
| Entity Emerging Growth Company | false |