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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.
 
DevicePRO-KINETIC ENERGY COBALT CHROMIUM (CoCr) CORONARY STENT SYSTEM
Classification Namestent, coronary
Generic Namestent, coronary
Applicant
BIOTRONIK, INC.
6024 jean road
lake oswego, OR 97035
PMA NumberP160003
Date Received01/19/2016
Decision Date02/14/2017
Product Code
MAF[ Registered Establishments with MAF ]
Docket Number 16M-2652
Notice Date 02/17/2017
Advisory Committee Cardiovascular
Clinical Trials NCT01612767
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the PRO-Kinetic Energy Cobalt Chromium (CoCr) Coronary Stent System. This device is indicated for improving coronary luminal diameter in patients with de novo or restenotic lesions in native coronary arteries with a reference vessel diameter ranging from 2.25 mm to 4.0 mm and lesion length <= 31 mm.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 
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