FLAIR ENDOVASCULAR STENT GRAFT WITH OPTIMIZED DELIVERY SYSTEM
FDA premarket approval P060002/S002 · decided 2008-10-28
Approval details
- PMA number
- P060002
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FLAIR ENDOVASCULAR STENT GRAFT WITH OPTIMIZED DELIVERY SYSTEM
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Applicant
- Bard Peripheral Vascular
- Date received
- 2008-03-20
- Decision date
- 2008-10-28
- Days to decision
- 222 days
- Decision code
- APPR
- Product code
- PFV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- 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.
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