PMA P130029S011
- Device
- Fluency® Plus Endovascular Stent Graft
- Applicant
- Bard Peripheral Vascular, Inc.
- PMA number
- P130029
- Supplement
- S011
- Product code
- PFV
- Decision date
- 2021-11-23
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Approval order statement
- Approval for modifying the materials of the packaging sterile barrier.
Current openFDA PMA Record#
- Device
- Fluency® Plus Endovascular Stent Graft
- Applicant
- Bard Peripheral Vascular, Inc.
- PMA number
- P130029
- Supplement
- S011
- Product code
- PFV
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Decision date
- 2021-11-23
- Decision code
- APPR
- Date received
- 2021-08-26
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for modifying the materials of the packaging sterile barrier.