WRAPSODY® Cell-Impermeable Endoprosthesis
FDA premarket approval P240023/S005 · decided 2026-06-11
Approval details
- PMA number
- P240023
- Supplement
- S005
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- 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
- 2026-05-13
- Decision date
- 2026-06-11
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- PFV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- South Jordan, UT
- Statement
- a duplicate manufacturing line for the Wrapsody Cell-Impermeable Endoprosthesis
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