PMA P060002S003
- Device
- FLAIR ENDOVASCULAR STENT GRAFT
- Applicant
- Bard Peripheral Vascular
- PMA number
- P060002
- Supplement
- S003
- Product code
- PFV
- Decision date
- 2008-09-23
- 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 TO ADD A SPECIFICATION AND INSPECTION PROCEDURE TOR THE Y-INJECTION-ADAPTER COMPONENT.
Current openFDA PMA Record#
- Device
- FLAIR ENDOVASCULAR STENT GRAFT
- Applicant
- Bard Peripheral Vascular
- PMA number
- P060002
- Supplement
- S003
- Product code
- PFV
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Decision date
- 2008-09-23
- Decision code
- APPR
- Date received
- 2008-08-29
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL TO ADD A SPECIFICATION AND INSPECTION PROCEDURE TOR THE Y-INJECTION-ADAPTER COMPONENT.