- Device
- Bard Fluency Plus Endovascular Stent Graft
- Applicant
- Bard Peripheral Vascular, Inc.
- PMA number
- P130029
- Supplement
- S010
- Product code
- PFV
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Decision date
- 2021-08-05
- Decision code
- OK30
- Date received
- 2021-07-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement an alternative external process challenge device (ePCD) used in the sterilization process.