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# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries-9/
- Published: 2020-05-31T12:00:00.000Z
- Updated: 2026-09-14T16:16:33.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5136515

**DEVICES**

FDA has approved a **Boston Scientific** PMA for the Emblem MRI Subcutaneous Implantable Defibrillator (S-ICD) System, as well as magnetic resonance (MR) conditional labeling for all previously implanted Emblem S-ICD Systems. “Now with FDA approval, patients receiving the Emblem MRI S-ICD System, as well as patients who previously were implanted with an Emblem S-ICD System, have reassurance they can safely undergo MR scans while remaining protected from cardiac arrest,” the company says.

**Centric Medical** has received FDA 510(k) clearance for the Hammertoe Correction System. The device offers a dual threaded design and is inserted between the proximal and middle phalanges, so that the opposing threads fixate on the phalangeal canal of the toe and compress the joint, according to the company. The current standard of care for hammertoe correction is to treat patients with wire pins, and many patients complain about the inconveniences that come with these because they are exposed out the end of the phalange for multiple weeks until they are surgically removed, it says. In contrast, the Hammertoe Correction System allows the implant to remain within the bone, eliminating the need for the follow up surgery to remove the pins.

FDA has cleared a **D R Burton Healthcare Products** 510(k) for its iPEP system, an oscillating positive expiratory pressure product. The device is intended to measure patient inspiratory capacity, according to the company. It combines two standard of care therapies — “the inspiratory capacity measurement associated with an incentive spirometer along with the benefits of oscillating positive expiratory pressure,” it says. The iPEP is designed to reduce the risk of hospital-acquired pneumonia, and such risks after patient discharge.

**Edwards Lifesciences Corp.** has received FDA approval of the advanced Edwards Intuity Elite valve system, a rapid deployment device for surgical aortic valve replacement. The company says it is built on the Perimount tissue valve platform and is designed to facilitate minimally invasive surgery and streamline complex aortic valve replacements.

**DRUGS**  
  
FDA has approved **Heron Therapeutics’** Sustol (granisetron) extended-release injection, a serotonin-3 (5-HT3) receptor antagonist indicated in combination with other antiemetics in adults for preventing acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide combination chemotherapy regimens. The product uses Heron’s Biochronomer polymer-based drug delivery technology to maintain therapeutic levels of granisetron for five days and longer, covering both the acute and delayed phases of chemotherapy-induced nausea and vomiting.