WRAPSODY Device Patent Review Locked in by FDA
Published Date: 2/26/2026
Notice
Summary
The FDA has officially set the review period for the MERIT MEDICAL WRAPSODY device, which helps extend its patent protection. This means the company can apply for extra patent time, giving them more control over their invention. If anyone thinks the dates are wrong or the company wasn’t careful during the review, they can speak up by April or August 2026.
Analyzed Economic Effects
3 provisions identified: 3 benefits, 0 costs, 0 mixed.
Applicant requests 908‑day patent extension
Merit Medical Systems filed patent-term restoration applications for U.S. Patent Nos. 10,005,269 and 10,028,852 and, in its USPTO application, seeks 908 days of patent term extension. The FDA notes its determination establishes the maximum potential length, and the USPTO will apply statutory limitations when calculating the actual extension.
FDA sets WRAPSODY review period
The FDA determined the regulatory review period for MERIT MEDICAL WRAPSODY is 1,639 days total, including 1,462 days of testing and 177 days of approval. Key dates the FDA verified are: investigational device exemption effective June 26, 2020; premarket approval (PMA P240023) submitted June 26, 2024; and PMA approval on December 19, 2024.
Public comment and petition deadlines
Anyone who believes the published dates are incorrect may ask FDA for a redetermination by April 27, 2026. Any interested person who believes the applicant did not act with due diligence during the regulatory review period may petition FDA by August 25, 2026.
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Key Dates
Department and Agencies
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