FLUENCY PLUS ENDOVASCULAR STENT GRAFT
FDA premarket approval P130029/S003 · decided 2015-07-15
Approval details
- PMA number
- P130029
- Supplement
- S003
- Supplement type
- Special (Immediate Track)
- 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
- 2015-06-15
- Decision date
- 2015-07-15
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- PFV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- APPROVAL TO IMPLEMENT AN ADDITIONAL QUALITY CONTROL INSPECTION STEP.
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