|
Device | BARD FLAIR ENDOVASCULAR STENT GRAFT |
Generic Name | System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment |
Applicant | BARD PERIPHERAL VASCULAR 1625 W. THIRD ST TEMPE, AZ 85281 |
PMA Number | P060002 |
Supplement Number | S014 |
Date Received | 07/28/2010 |
Decision Date | 08/13/2010 |
Withdrawal Date
|
09/12/2022 |
Product Code |
PFV |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement REVISED FORMULATION FOR THE ADHESIVE USED DURING MANUFACTURING. |