WRAPSODY Cell-Impermeable Endoprosthesis
FDA premarket approval P240023/S002 · decided 2025-02-12
Approval details
- PMA number
- P240023
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- 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
- 2025-01-15
- Decision date
- 2025-02-12
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- PFV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- South Jordan, UT
- Statement
- approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P240023.
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