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: MAGIC WALLSTENT ENDOPROTHESIS NATIVE CORONARY INDICATION
• Generic Name: STENT, CORONARY
• Applicant: Boston Scientific Scimed, Inc.; Two Scimed Pl.; Maple Grove, MN
• PMA Number: P980009
• Supplement Number: S001
• Date Received: 10/30/1998
• Decision Date: 01/27/1999
• Withdrawal Date: 09/28/2007
• Product Code: MAF
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Postapproval Study Protocol
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for protocol for the post approval study.