Premarket Approval (PMA)

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.

• Device: Resolute Onyx Zotarolimus-Eluting Coronary Stent System
• Generic Name: Coronary drug-eluting stent
• Applicant: Medtronic Vascular; 3576 Unocal Pl.; Santa Rosa, CA 95403
• PMA Number: P160043
• Supplement Number: S006
• Date Received: 08/16/2017
• Decision Date: 09/13/2017
• Product Code: NIQ
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Implement a new piece of equipment used to apply the hydrophilic coating to the Resolute Onyx catheter shaft.