ReShape Lifesciences® Receives FDA PMA Supplement Approval for its Next-Generation Lap-Band® 2.0 FLEX
IRVINE, Calif., Dec. 12, 2023 (GLOBE NEWSWIRE) -- ReShape Lifesciences® (Nasdaq: RSLS), the premier physician-led weight loss and metabolic health solutions company, today announced that the U.S. Food and Drug Administration (FDA) has granted approval of a PMA supplement for the company’s next generation, enhanced Lap-Band® 2.0 FLEX.
- IRVINE, Calif., Dec. 12, 2023 (GLOBE NEWSWIRE) -- ReShape Lifesciences ® (Nasdaq: RSLS), the premier physician-led weight loss and metabolic health solutions company, today announced that the U.S. Food and Drug Administration (FDA) has granted approval of a PMA supplement for the company’s next generation, enhanced Lap-Band® 2.0 FLEX.
- “PMA supplement approval for our next generation Lap-Band® 2.0 FLEX is a historic event for ReShape that is expected to be a key growth catalyst for the company’s Lap-Band® franchise,” stated Paul F. Hickey, President and Chief Executive Officer of ReShape Lifesciences.
- “The enhanced Lap-Band® 2.0 FLEX development effort was physician-led with the goal of improving the patient experience.
- “Lap-Band 2.0® FLEX will potentially remedy this issue because of the ability for self-correction, utilizing an internal reservoir system.