EPIC SELF-EXPANDING NITINOL STENT SYSTEM
FDA premarket approval P110035 · decided 2012-04-13
Approval details
- PMA number
- P110035
- Trade name
- EPIC SELF-EXPANDING NITINOL STENT SYSTEM
- Generic name
- STENT, ILIAC
- Applicant
- Boston Scientific Corp
- Date received
- 2011-09-13
- Decision date
- 2012-04-13
- Days to decision
- 213 days
- Decision code
- APPR
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Galway
- Statement
- APPROVAL FOR THE EPIC VASCULAR SELF-EXPANDING STENT SYSTEM. THIS DEVICE IS INDICATED FOR THE IMPROVEMENT OF LUMINAL DIAMETER IN PATIENTS WITH DE NOVO OR RESTENOTIC SYMPTOMATIC ATHEROSCLEROTIC LESIONS UP TO 120 MM IN LENGTH IN THE COMMON AND/OR EXTERNAL ILIAC ARTERIES, WITH A REFERENCE VESSEL DIAMETER BETWEEN 5 AND 11 MM.
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510(k) clearances by this applicant
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|---|---|---|
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