federal_register: E8-30439
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
This data as json
| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| E8-30439 | General and Plastic Surgery Devices: Proposed Classification for the Tissue Expander | Proposed Rule | The Food and Drug Administration (FDA) is proposing to classify into class II (special controls) the tissue expander, as a device intended for temporary (less than 6 months) subdermal implantation to stretch the skin for surgical applications, specifically to develop surgical flaps and additional tissue coverage. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the draft guidance that FDA intends will serve as the special control if FDA classifies this device type into class II. | 2008-12-22 | 2008 | 12 | https://www.federalregister.gov/documents/2008/12/22/E8-30439/general-and-plastic-surgery-devices-proposed-classification-for-the-tissue-expander | https://www.govinfo.gov/content/pkg/FR-2008-12-22/pdf/E8-30439.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is proposing to classify into class II (special controls) the tissue expander, as a device intended for temporary (less than 6 months) subdermal implantation to stretch the skin for surgical applications,... |