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# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries-17/
- Published: 2021-09-12T12:00:00.000Z
- Updated: 2026-09-14T17:14:13.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5132730

**DEVICES**

FDA has granted 510(k) clearance to **Joimax** to market its Endoscopic Lumbar Interbody Fusion, or EndoLIF On-Cage implant. According to the company,the implant allows surgeons to use an inter-muscular approach, similar to a mini transforaminal lumbar interbody fusion, into the intervertebral disc, enabling endoscopic-assisted fusion.

**Magellan Diagnostics** has received FDA 510(k) clearance to market the LeadCare Plus Blood Lead Testing System in the U.S. for the quantification of lead levels in blood. The company says the system has a compact footprint with dimensions smaller than a laptop. It also has single-use consumables and electronic calibration.

**Novo Nordisk** has received FDA approval of FlexPro PenMate, designed for users of Norditropin FlexPro 5 mg, 10 mg, and 15 mg pens who dislike needles and prefer them to be hidden during the injection process.

**Qiagen** received FDA approval of a PMA for its therascreen EGFR RGQ PCR Kit as a companion diagnostic to guide the use of AstraZeneca’s Iressa (gefitinib) in treating patients with advanced or metastatic non-small cell lung cancer.

**Remedium Technologies** has received FDA 510(k) clearance of its Hemogrip Patch indicated for use at vascular access sites, where it rapidly controls bleeding that occurs when accessing veins or arteries for various medical treatments and applications.

**HUMAN DRUGS**

**Veloxis Pharmaceuticals** has received FDA approval of Envarsus XR (tacrolimus extended-release tablets) for the prophylaxis of rejection in kidney transplant patients who require or desire conversion from other twice-daily tacrolimus products to once-daily Envarsus XR.