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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.
 
DevicePRO-Kinetic Energy Coronary Stent System
Generic NameSTENT, CORONARY
ApplicantBiotronik AG
Ackerstrasse 6
Bülach 8180
PMA NumberP160003
Supplement NumberS002
Date Received04/19/2017
Decision Date04/25/2018
Product Code MAF 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for modifications to the incubation conditions used during bioburden testing of the product and environment.
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