PMA P130029S004
- Device
- FLUENCY PLUS ENDOVASCULAR STENT GRAFT
- Applicant
- Bard Peripheral Vascular, Inc.
- PMA number
- P130029
- Supplement
- S004
- Product code
- PFV
- Decision date
- 2016-08-24
- 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 a manufacturing site located at Sterigenics Belgium Petit-Rechain S.A., Zoning Industriel de petit-Rechain, Avenue Andre Ernst 21, Petit-Rechain, Verviers, 4800, Belgium, for contract sterilization.
Current openFDA PMA Record#
- Device
- FLUENCY PLUS ENDOVASCULAR STENT GRAFT
- Applicant
- Bard Peripheral Vascular, Inc.
- PMA number
- P130029
- Supplement
- S004
- Product code
- PFV
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Decision date
- 2016-08-24
- Decision code
- APPR
- Date received
- 2016-02-12
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at Sterigenics Belgium Petit-Rechain S.A., Zoning Industriel de petit-Rechain, Avenue Andre Ernst 21, Petit-Rechain, Verviers, 4800, Belgium, for contract sterilization.