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# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries-31/
- Published: 2022-01-02T12:00:00.000Z
- Updated: 2026-09-14T17:26:25.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137213

**BIOLOGICS**

FDA has approved an **Ethicon** BLA supplement for an expanded indication for Evarrest Fibrin Sealant Patch, indicated for stopping problematic bleeding during surgery. It now supports the product’s use as an adjunctive hemostat across a broad range of challenging patient types and surgical situations.

**DEVICES**

FDA has approved a **St. Jude Medical** PMA for the Amplatzer PFO Occluder device to reduce the risk of a stroke in patients who previously had a stroke believed to be caused by a blood clot that passed through a small hole in the heart (patent foramen ovale) and then traveled to the brain. About 25% to 30% of Americans have a patent foramen ovale (PFO), which typically causes no health problems and does not require treatment.

FDA has approved a **Roche** PMA for the Ventana PD-L1 (SP142) Assay as a complementary diagnostic to identify PD-L1 expression levels in patients considering treatment with the company’s recently approved immunotherapy Tecentriq (atezolizumab) for previously treated metastatic non-small cell lung cancer. The assay is also indicated to identify patients with urothelial cancer who may benefit from the therapy.

FDA has approved **Medtronic**’s CoreValve Evolut R 34 mm valve, said to be the largest sized transcatheter aortic valve replacement system available in the U.S. The device is approved for severe aortic stenosis patients who are at high or extreme risk for surgery with an annulus size ranging from 26-30 mm.

**DRUGS**

FDA has approved a **Merck** NDA for Zinplava (bezlotoxumab) injection 25 mg/mL, indicated for reducing recurrence of *Clostridium difficile* infection (CDI) in patients 18 years of age or older who are receiving antibacterial drug treatment and are at high risk for CDI recurrence. The company notes that the therapy is not indicated for treating CDI, and it is not an antibacterial drug, which is why it should only be used in conjunction with antibacterial drug treatment.