WRAPSODY® Cell-Impermeable Endoprosthesis
FDA premarket approval P240023 · decided 2024-12-19
Approval details
- PMA number
- P240023
- Trade name
- WRAPSODY® Cell-Impermeable Endoprosthesis
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Applicant
- Merit Medical Systems, Inc.
- Date received
- 2024-06-26
- Decision date
- 2024-12-19
- Days to decision
- 176 days
- Decision code
- APPR
- Product code
- PFV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- South Jordan, UT
- Statement
- Approval for Merit Medical Systems, Inc. WRAPSODY Cell-Impermeable Endoprosthesis. This device is indicated for use in hemodialysis patients for the treatment of stenosis or occlusion within the dialysis access outflow circuit, including stenosis or occlusion in the peripheral veins of individuals with an arteriovenous (AV) fistula or at the venous anastomosis of a synthetic AV graft.
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