FLUENCY PLUS ENDOVASCULAR STENT GRAFT
FDA premarket approval P130029/S004 · decided 2016-08-24
Approval details
- PMA number
- P130029
- Supplement
- S004
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FLUENCY PLUS ENDOVASCULAR STENT GRAFT
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Applicant
- Bard Peripheral Vascular, Inc.
- Date received
- 2016-02-12
- Decision date
- 2016-08-24
- Days to decision
- 194 days
- Decision code
- APPR
- Product code
- PFV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- 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.
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