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# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries-14/
- Published: 2021-08-22T12:00:00.000Z
- Updated: 2026-09-14T17:11:20.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141177

**DEVICES**

FDA has approved a **W. L. Gore** expanded indication for its Gore Cardioform Septal Occluder for *patent foramen ovale* (PFO) closure to prevent recurrent ischemic strokes. The device was previously approved for closure of atrial septal defects up to 17 mm. The expanded was supported by data from the REDUCE study, which was published in the *New England Journal of Medicine* 9/2017.

FDA has approved an expanded indication for **Cardiva Medical**’s Vascade vascular closure system for use in 5-7F femoral venous closures as well as for arterial closure. The company says the expanded indication “creates an opportunity to better treat patients undergoing interventional cardiac catheterization procedures, while also greatly increasing the available market for Vascade.”

**DRUGS**

FDA has approved an **AstraZeneca** NDA for Bydureon (exenatide extended-release) for injectable suspension as an add-on therapy to basal insulin in adults with Type 2 diabetes with inadequate glycemic control. The expanded use is based on data from the 28-week DURATION-7 study, which examined the effect of Bydureon or placebo as add-on therapy to insulin glargine, with or without metformin.