PMA P130029S007
- Device
- Fluency Plus Endovascular Stent Graft
- Applicant
- Bard Peripheral Vascular, Inc.
- PMA number
- P130029
- Supplement
- S007
- Product code
- PFV
- Decision date
- 2017-10-05
- Classification
- System, Endovascular Graft, Arteriovenous (av) Dialysis Access Circuit Stenosis Treatment
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Approval order statement
- Approval for an update to the labeling to include the 24-month data on patients enrolled in the clinical study.
Current openFDA PMA Record#
- Device
- Fluency Plus Endovascular Stent Graft
- Applicant
- Bard Peripheral Vascular, Inc.
- PMA number
- P130029
- Supplement
- S007
- Product code
- PFV
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Decision date
- 2017-10-05
- Decision code
- APPR
- Date received
- 2017-04-10
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for an update to the labeling to include the 24-month data on patients enrolled in the clinical study.