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# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries-32/
- Published: 2022-01-09T12:00:00.000Z
- Updated: 2026-09-14T17:27:56.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141279

**DEVICES**

FDA has approved a **Sientra** PMA supplement allowing commercialization of its Opus-branded breast implant products manufactured by Vesta, a Lubrizol LifeSciences company, at Vesta’s Wisconsin-based manufacturing facility. The devices are being made under “an improved manufacturing process,” according to Sientra.

FDA has cleared a **Varian** 510(k) for its Calypso Anchored Beacon transponder. Used with Varian’s TrueBeam, Edge and Clinac C-series medical linear accelerators, the transponder detects slight movements of a tumor and helps clinicians deliver lung stereotactic body radiotherapy.

**DRUGS**

FDA has expanded approval for **AstraZeneca**’s Tagrisso (osimertinib) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) mutations (exon 19 deletions or exon 21 L858R mutations), as detected by an FDA-approved test.

FDA has approved a **Rigel Pharmaceuticals** NDA for Tavalisse (fostamatinib disodium hexahydrate) for treating thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment.