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: TAXUS LIBERTE PACILITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL)
• Generic Name: Coronary drug-eluting stent
• Applicant: Boston Scientific Corp; One Scimed Pl.; Maple Grove, MN 55311
• PMA Number: P060008
• Supplement Number: S095
• Date Received: 09/04/2012
• Decision Date: 09/21/2012
• Withdrawal Date: 12/06/2018
• Product Code: NIQ
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

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