EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM
FDA premarket approval P090003 · decided 2010-03-05
Approval details
- PMA number
- P090003
- Trade name
- EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM
- Generic name
- STENT, ILIAC
- Applicant
- Boston Scientific Corporation
- Date received
- 2009-02-23
- Decision date
- 2010-03-05
- Days to decision
- 375 days
- Decision code
- APPR
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR THE EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM. THE DEVICE IS INDICATED FOR THE TREATMENT OF ATHEROSCLEROTIC LESIONS FOUND IN ILIAC ARTERIES UP TO 100 MM IN LENGTH, WITH A REFERENCE DIAMETER OF 6 MM TO 10 MM.
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