PMA P060002S002
- Device
- FLAIR ENDOVASCULAR STENT GRAFT WITH OPTIMIZED DELIVERY SYSTEM
- Applicant
- Bard Peripheral Vascular
- PMA number
- P060002
- Supplement
- S002
- Product code
- PFV
- Decision date
- 2008-10-28
- 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 THE OPTIMIZED DELIVERY SYSTEM, THE TRANSFER OF MANUFACTURING OF THE DELIVERY SYSTEM TO ANGIOMED GMBH & CO., KARLSRUHE, GERMANY, AND THE TRANSFER OF STERILIZATION TO BARD MEDICAL DIVISION REGIONAL STERILIZATION AND REGIONAL STERILIZATION MADISON OPERATION, IN COVINGTON, GEORGIA, AND MADISON, GEORGIA, RESPECTIVELY.
Current openFDA PMA Record#
- Device
- FLAIR ENDOVASCULAR STENT GRAFT WITH OPTIMIZED DELIVERY SYSTEM
- Applicant
- Bard Peripheral Vascular
- PMA number
- P060002
- Supplement
- S002
- Product code
- PFV
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Decision date
- 2008-10-28
- Decision code
- APPR
- Date received
- 2008-03-20
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE OPTIMIZED DELIVERY SYSTEM, THE TRANSFER OF MANUFACTURING OF THE DELIVERY SYSTEM TO ANGIOMED GMBH & CO., KARLSRUHE, GERMANY, AND THE TRANSFER OF STERILIZATION TO BARD MEDICAL DIVISION REGIONAL STERILIZATION AND REGIONAL STERILIZATION MADISON OPERATION, IN COVINGTON, GEORGIA, AND MADISON, GEORGIA, RESPECTIVELY.