FLUENCY PLUS ENDOVASCULAR STENT GRAFT
FDA premarket approval P130029/S006 · decided 2017-11-28
Approval details
- PMA number
- P130029
- Supplement
- S006
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process 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
- 2016-11-30
- Decision date
- 2017-11-28
- Days to decision
- 363 days
- Decision code
- APPR
- Product code
- PFV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- 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.
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