21 CFR Chapter I Subchapter H β Medical Devices β Part 876 Gastroenterology-Urology Devices From Food and Drug Administration (FDA) πΊπΈ Regulation on Gastroenterology-Urology Devices under 21 CFR Chapter I Subchapter H - Medical Devices, Part 876. Metadata quality: Metadata quality: Data description filled Files documented License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 77.77777777777779/100 Updated 2 days ago Other (Public Domain) 0 reuses 0 favorites
Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems - Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) πΊπΈ This document is a guidance for industry and FDA staff on non-clinical engineering tests and labeling for intravascular stents and delivery systems. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on August 9, 2024 Other (Public Domain) 0 reuses 0 favorites
Metal Expandable Biliary Stents - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document is a guidance for industry and FDA staff on premarket notification submissions for metal expandable biliary stents. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on August 9, 2024 Other (Public Domain) 0 reuses 0 favorites
DSVG 02 on Coronary stents From European Commission πͺπΊ This document titled "DSVG 02 on Coronary stents" discusses post-market surveillance and vigilance for coronary stents. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on January 30, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
21 CFR Chapter I Subchapter H β Medical Devices β Part 884 Obstetrical and Gynecological Devices From Food and Drug Administration (FDA) πΊπΈ This document is a regulation titled "21 CFR Chapter I Subchapter H β Medical Devices β Part 884 Obstetrical and Gynecological Devices". Metadata quality: Metadata quality: Data description filled Files documented License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 77.77777777777779/100 Updated on March 31, 2023 Other (Public Domain) 0 reuses 0 favorites
Recommendations from the independent Expert Advisory Group on the use of Paclitaxel Drug-Coated Balloons and Drug-Eluting Stents to the MHRA From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ The findings and recommendations of the Expert Advisory Group on paclitaxel drug-coated balloon catheters and drug-eluting stents which are used to treat patients with peripheral arterial disease. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on February 18, 2021 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Notice on Strengthening the Quality Supervision of Selected Coronary Stents in National Centralized Banded Purchasing by the Comprehensive Department of the State Drug Administration (SDA) From National Medical Products Administration (NMPA) π¨π³ FGWJ-2020-10001 Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on November 11, 2020 Other (Public Domain) 0 reuses 0 favorites
Guidance for the Content of Premarket Notifications for Ureteral Stents From Food and Drug Administration (FDA) πΊπΈ This document provides guidance for the content of premarket notifications for ureteral stents. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on March 17, 2020 Other (Public Domain) 0 reuses 0 favorites
Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document is a guidance for industry and FDA staff on updates for non-clinical engineering tests and labeling for intravascular stents and delivery systems. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on March 18, 2019 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Gastroenterology-Urology Devices; Classification of the Metallic Biliary Stent System for Benign Strictures From Food and Drug Administration (FDA) πΊπΈ Document number 2016-16530. The Food and Drug Administration (FDA) is classifying the metallic biliary stent system for benign strictures into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language forβ¦ Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on July 13, 2016 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Gastroenterology-Urology Devices; Classification of Pancreatic Drainage Stent and Delivery System From Food and Drug Administration (FDA) πΊπΈ Document number 2014-12297. The Food and Drug Administration (FDA) is classifying the pancreatic drainage stent and delivery system into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of the codified language for theβ¦ Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on May 29, 2014 Other (Public Domain) 0 reuses 0 favorites