|
Device | FLUENCY PLUS ENDOVASCULAR STENT GRAFT |
Generic Name | System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment |
Applicant | BARD PERIPHERAL VASCULAR, INC. 1415 WEST 3RD ST. TEMPE, AZ 85281 |
PMA Number | P130029 |
Supplement Number | S006 |
Date Received | 11/30/2016 |
Decision Date | 11/28/2017 |
Product Code |
PFV |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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. |