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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 NumberS024
Date Received03/05/2025
Decision Date06/05/2026
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  
the introduction of a new production site for supply of the hypotube and a new hypotube extrusion process
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