PMA P060002S038
- Device
- FLAIR ENDOVASCULAR STENT GRAFT
- Applicant
- Bard Peripheral Vascular
- PMA number
- P060002
- Supplement
- S038
- Product code
- PFV
- Decision date
- 2017-11-28
- 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 inspection procedure for the bond peel strength test for the FLAIR® and FLUENCY® plus endovascular stent graft systems.
Current openFDA PMA Record#
- Device
- FLAIR ENDOVASCULAR STENT GRAFT
- Applicant
- Bard Peripheral Vascular
- PMA number
- P060002
- Supplement
- S038
- Product code
- PFV
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Decision date
- 2017-11-28
- Decision code
- APPR
- Date received
- 2016-11-30
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for an update to the inspection procedure for the bond peel strength test for the FLAIR® and FLUENCY® plus endovascular stent graft systems.