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BOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM

FDA premarket approval P060006 · decided 2008-12-11

Approval details

PMA number
P060006
Trade name
BOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM
Generic name
STENT, RENAL
Applicant
Boston Scientific Corp
Date received
2006-02-21
Decision date
2008-12-11
Days to decision
1024 days
Decision code
APPR
Product code
NIN
Advisory committee
Cardiovascular
Expedited review
No
Location
Maple Grove, MN
Statement
APPROVAL FOR THE BOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM. THE DEVICE IS INDICATED AS AN ADJUNCT TO PERCUTANEOUS TRANSLUMINAL RENAL ANGIOPLASTY (PTRA) OF A SINGLE DE NOVO OR RESTENOTIC ATHEROSCLEROTIC LESION (<=15 MM IN LENGTH) OF THE RENAL ARTERY, LOCATED WITHIN 5 MM OF THE OPACIFIED AORTIC LUMEN, WITH A REFERENCE VESSEL DIAMETER OF 4.0 ¿ 7.0 MM TO ASSIST IN THE MAINTENANCE OF VESSEL PATENCY.

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