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: EXPRESS CORONARY STENT SYSTEM (MONORAIL)
• Generic Name: STENT, CORONARY
• Applicant: BOSTON SCIENTIFIC SCIMED, INC.; ONE SCIMED PLACE; MAPLE GROVE, MN 55311-1566
• PMA Number: P020009
• Supplement Number: S091
• Date Received: 09/04/2012
• Decision Date: 09/21/2012
• Withdrawal Date: 12/06/2018
• Product Code: MAF
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
ALTERNATE EQUIPMENT FOR DISPENSING AND MIXING URETHANE ADHESIVE.