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: PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM
• Generic Name: Coronary drug-eluting stent
• Applicant: Boston Scientific Corp.; ONE SCIMED PLACE; MAPLE GROVE, MN 55311-1566
• PMA Number: P110010
• Supplement Number: S028
• Date Received: 08/24/2012
• Decision Date: 09/27/2012
• Product Code: NIQ
• Advisory Committee: Cardiovascular
• Supplement Type: Real-Time Process
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: No
• Combination Product: Yes

Approval Order Statement  
APPROVAL FOR REMOVAL OF THE BALL FROM THE TIP OF THE COREWIRE WHICH IS LOCATED BETWEEN THE INNER AND OUTER LUMEN OF THE STENT DELIVERY SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM AND ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM AND ARE INDICATED FOR IMPROVING LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE OR DOCUMENTED SILENT ISCHEMIA DUE TO DE NOVO LESIONS IN NATIVE CORONARY ARTERIES >=2.25 MM TO <=4.00 MM IN DIAMETER IN LESIONS <=34 MM IN LENGTH, AND FOR IMPROVING LUMINAL DIAMETER FOR THE TREATMENT OF DE NOVO LESIONS IN NATIVE CORONARY ARTERIES >2.25 MM TO <4.00 MM IN DIAMETER IN LESIONS <34 MM IN LENGTH, RESPECTIVELY