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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameREBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE
Classification Namestent, coronary
ApplicantBOSTON SCIENTIFIC CORP.
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Supplements: S001 S002 S003 
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