1. 公眾諮詢會議:2014/6/17舉行[Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement],討論、建議及投票PMA [the Maestro® Rechargeable System sponsored by Enteromedics, Inc.],本器材藉由非侵入式生理治療去減輕體重,並不會改變消化系統結構,進一步改善生活及食物選擇。

2. 新增P120020[Supera Peripheral Stent System](周邊血管支架系統)-使用者資訊及產品摘要資訊。

3. 公告草案指引(Draft Guidance)

- Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval - Draft Guidance for Industry and Food and Drug Administration Staff

- Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions - Draft Guidance for Industry and Food and Drug Administration Staff

4. 新增2014/4/24 Neurological Devices Panel of the Medical Devices Advisory Committee Meeting的資料。

5. 新增2014/3/27 Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee Meeting會議抄本。

6. 新增P100020/S008 [cobas® HPV Test] -產品摘要資訊。

參考資料:

U.S. FDA CDRHNews http://www.fda.gov/MedicalDevices/NewsEvents/News/default.htm#

 

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