BARD E-LUMINEXX VASCULAR STENT
FDA premarket approval P080007 · decided 2008-12-04
Approval details
- PMA number
- P080007
- Trade name
- BARD E-LUMINEXX VASCULAR STENT
- Generic name
- STENT, ILIAC
- Applicant
- Bard Peripheral Vascular, Inc.
- Date received
- 2008-03-21
- Decision date
- 2008-12-04
- Days to decision
- 258 days
- Decision code
- APPR
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- APPROVAL FOR THE BARD E.LUMINEXX VASULAR STENT. THE DEVICE IS INDICATED FOR THE TREATMENT F ILIAC OCCLUSIVE DISEASE IN PATIENTS WITH SYMPTOMATIC VASCULAR DISEASE OF THE COMMON AND/OR EXTERNAL ILIAC ARTERIES UP TO 126 MM IN LENGTH, WITH A REFERENCE VESSEL DIAMETER OF 5 TO 9 MM.
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