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# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries-46/
- Published: 2022-04-10T12:00:00.000Z
- Updated: 2026-09-14T17:40:01.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137039

**DEVICES**

**St. Jude Medical** has gained PMA approval for the Infinity Deep Brain Stimulation (DBS) system and its DBS directional leads, which the company describes as the first directional lead approved in the U.S. The device is intended to treat two of the most common movement disorders — Parkinson’s disease and essential tremor.

FDA has approved a label extension for **Roche**’s EGFR Mutation Test v2 for use with plasma samples as a companion diagnostic for Astra Zeneca’s Tagrisso (osimertinib), which is indicated for patients with metastatic epidermal growth factor receptor mutation-positive non-small cell lung cancer.

**Adapta Medical** has gained 510(k) clearance for the PerfIC Cath intermittent touchless urinary catheter. It is designed for those with a spinal cord injury, multiple sclerosis, diabetes, stroke, spina bifida or other conditions that require a catheter.

**DRUGS**

FDA has approved **Lundbeck**’s Carnexiv (carbamazepine) injection as a short-term replacement therapy for carbamazepine formulations in adults with certain seizure types when oral administration is temporarily not feasible.

The agency has approved an **Orexo U.S.** supplemental NDA for Zubsolv (buprenorphine/naloxone sublingual tablet) 0.7mg/0.18mg for treating patients with opioid dependence.