PMA P240023S002

Device: WRAPSODY Cell-Impermeable Endoprosthesis
Applicant: Merit Medical Systems, Inc.
PMA number: P240023
Supplement: S002
Product code: PFV
Decision date: 2025-02-12
Classification: Cardiovascular
Generic name: System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
Approval order 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.

Current openFDA PMA Record#

Device: WRAPSODY Cell-Impermeable Endoprosthesis
Applicant: Merit Medical Systems, Inc.
PMA number: P240023
Supplement: S002
Product code: PFV
Generic name: System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
Decision date: 2025-02-12
Decision code: APPR
Date received: 2025-01-15
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order 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.