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: ENROUTE TRANSCAROTID STENT SYSTEM
• Generic Name: Stent, carotid
• Applicant: Boston Scientific Corporation; 300 Boston Scientific Way; Marborough, MA 01752
• PMA Number: P140026
• Supplement Number: S001
• Date Received: 06/05/2015
• Decision Date: 08/03/2015
• Product Code: NIM
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol - OSB
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL OF THE POST APPROVAL STUDY PROTOCOL.