Bard Fluency Plus Endovascular Stent Graft
FDA premarket approval P130029/S008 · decided 2020-05-29
Approval details
- PMA number
- P130029
- Supplement
- S008
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Bard Fluency Plus Endovascular Stent Graft
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Applicant
- Bard Peripheral Vascular, Inc.
- Date received
- 2020-05-01
- Decision date
- 2020-05-29
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- PFV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- Qualification of lasers currently used in manufacturing for additional purposes.
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