> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries/
- Published: 2019-11-03T12:00:00.000Z
- Updated: 2026-09-14T15:51:36.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5136849

**DEVICES**

FDA has approved an **Acclarent** *de novo* petition to permit marketing of the Aera Eustachian Tube Balloon Dilation System for treating persistent eustachian tube dysfunction (ETD), a condition in which pressure, pain or clogged or muffled sensations occur in the ear.

FDA has approved a **Medtronic** PMA for the IN.PACT Admiral drug-coated balloon for treating in-stent restenosis in patients with peripheral artery disease. This is the first drug-coated balloon approved to treat in-stent restenosis in the U.S.

**Carl Zeiss Meditec** has gained PMA approval for the VisuMax Femtosecond Laser for the small incision lenticule extraction procedure to reduce or eliminate nearsightedness in certain patients 22 years of age or older. The device removes a small amount of eye tissue to permanently reshape the cornea.

**Obalon Therapeutics** has won PMA approval for the Obalon Balloon System, a nonsurgical, reversible device for weight loss. The swallowable intragastric balloon device is indicated for temporary use to facilitate weight loss in adults with obesity who have failed to lose weight through diet and exercise

**DRUGS**

FDA has approved an **Aralez Pharmaceuticals** NDA resubmission for Yosprala (aspirin and omeprazole), indicated for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.

A **Glenmark Pharmaceuticals** ANDA has been granted final FDA approval for diclofenac sodium gel, 3%, the generic version of Fougera Pharmaceuticals’ Solaraze Gel, indicated for treating actinic keratoses, a precancerous skin growth usually caused by sun exposure.