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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceNIROYAL(R) ELITE PREMOUNTED STENT SYSTEM
ApplicantBoston Scientific Corp
One Boston Scientific Pl.
Natick,, MA 01760
PMA NumberP980001
Supplement NumberS023
Date Received08/03/2000
Decision Date01/25/2001
Withdrawal Date08/13/2007
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR ADDITIONAL STENT LENGTHS (I.E., 9 MM, 12 MM AND 18 MM) FOR THE NIROYAL(TM) ELITE PREMOUNTED STENT SYSTEM. THE DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN THE FOLLOWING: 1) PATIENTS WITH SYNPTOMATIC ISCHEMIC DISEASE ASSOCIATED WITH STENOTIC LESIONS IN NATIVE CORONARY ARTERIES (LENGTH <=25 MM) IN REFERENCE VESSEL DIAMETER OF 3.0 TO 4.0 MM; 2) TREATMENT OF ABRUPT OR THREATENED CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN LESIONS WITH REFERENCE DIAMETERS IN THE RANGE OF 2.5 TO 4.0 MM; AND 3) PATIENTS WITH SYNPTOMATIC HEART DISEASE DUE TO LESIONS IN SAPHENOUS VEIN BYPASS GRAFTS WITH LESION LENGTH <=30 MM AND REFERENCE DIAMETER IN THE RANGE OF 3.0 TO 4.0 MM.
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