The following new items were added to the CDRH web pages on July 25, 2018. Previous CDRH Newitems can be found on the CDRH New webpage.
- Consumer Information on: Minimed 670G System - P160017/S031
- UPDATE: Zoll LifeVest 4000 Wearable Cardioverter Defibrillator - Potential Lack of Treatment (Shock) Delivery Due to Device Failure: FDA Safety Communication
- UPDATED: Examples of Pre-Market Submissions that Include MMAs Cleared or Approved by FDA
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