EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM
FDA premarket approval P110023/S007 · decided 2014-10-10
Approval details
- PMA number
- P110023
- Supplement
- S007
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Medtronic Vascular, Inc.
- Date received
- 2014-04-14
- Decision date
- 2014-10-10
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL FOR THE EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM. THIS DEVICE IS INDICATED FOR IMPROVING LUMINAL DIAMETER IN PATIENTS WITH ATHEROSCLEROTIC DISEASE IN THE COMMON AND/OR EXTERNAL ILIAC ARTERIES UP TO AND INCLUDING 100 MM IN LENGTH, WITH A REFERENCE VESSEL DIAMETER OF 4.5 TO 7.5 MM.
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