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 Coronary Stent System
• Generic Name: coronary drug-eluting stent
• Applicant: MEDTRONIC VASCULAR; 3576 unocal place; santa rosa, CA 95403
• PMA Number: P160043
• Supplement Number: S037
• Date Received: 07/10/2020
• Decision Date: 10/05/2020
• Product Code: NIQ
• Advisory Committee: Cardiovascular
• Supplement Type: normal 180 day track no user fee
• Supplement Reason: location change - manufacturer/sterilizer/packager/supplier
• Expedited Review Granted?: No
• Combination Product: Yes

Approval Order Statement  
Approval for a site change for packaging and labeling rework processes.