PMA P240023
- Device
- WRAPSODY® Cell-Impermeable Endoprosthesis
- Applicant
- Merit Medical Systems, Inc.
- PMA number
- P240023
- Supplement
- S005
- Product code
- PFV
- Decision date
- 2026-06-11
- Classification
- Cardiovascular
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Approval order statement
- a duplicate manufacturing line for the Wrapsody Cell-Impermeable Endoprosthesis
Current openFDA PMA Record#
- Device
- WRAPSODY® Cell-Impermeable Endoprosthesis
- Applicant
- Merit Medical Systems, Inc.
- PMA number
- P240023
- Supplement
- S005
- Product code
- PFV
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Decision date
- 2026-06-11
- Decision code
- OK30
- Date received
- 2026-05-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a duplicate manufacturing line for the Wrapsody Cell-Impermeable Endoprosthesis