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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceREBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE
Classification Namestent, coronary
Generic Namestent, coronary
Applicant
Boston Scientific Corp.
one scimed place
maple grove, MN 55311-1566
PMA NumberP130030
Date Received12/30/2013
Decision Date06/27/2014
Product Code
MAF[ Registered Establishments with MAF ]
Docket Number 14M-1060
Notice Date 07/23/2014
Advisory Committee Cardiovascular
Clinical Trials NCT01419171
NCT01703000
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE). THIS DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH DE NOVO LESIONS <= 28 MM IN LENGTH IN NATIVE CORONARY ARTERIES WITH A REFERENCE VESSEL DIAMETER (RVD) OF >= 2.25 TO >= 4.50 MM.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S014 S015 S016 S017 S018 S019 
S020 S021 S022 S023 S024 S025 S026 S027 S028 
S030 S031 S032 S033 S034 S035 S036 S037 S038 
S039 S040 S041 S042 S043 S044 
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