ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM
FDA premarket approval P110011 · decided 2011-10-26
Approval details
- PMA number
- P110011
- Trade name
- ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM
- Generic name
- STENT, ILIAC
- Applicant
- Medtronic, Ireland
- Date received
- 2011-04-01
- Decision date
- 2011-10-26
- Days to decision
- 208 days
- Decision code
- APWD
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Galway
- Statement
- APPROVAL FOR THE ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM. THIS DEVICE IS INDICATED FOR IMPROVING ILIAC LUMINAL DIAMETER IN PATIENTS WITH DE NOVO AND RESTENOTIC LESIONS IN THE COMMON AND EXTERNAL ILIAC ARTERIES, WITH REFERENCE VESSEL DIAMETERS BETWEEN 6 MM AND 10 MM AND LESION LENGTHS UP TO 61 MM. THE STENT IS INTENDED AS A PERMANENT IMPLANT.
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