|
Device | MAGIC WALLSTENT ENDOPROTHESIS |
Generic Name | STENT, CORONARY |
Applicant | BOSTON SCIENTIFIC SCIMED, INC. TWO SCIMED PLACE MAPLE GROVE, MN |
PMA Number | P980009 |
Date Received | 04/01/1998 |
Decision Date | 09/29/1998 |
Withdrawal Date
|
09/28/2007 |
Product Code |
MAF |
Docket Number | 99M-2028 |
Notice Date | 06/24/1999 |
Advisory Committee |
Cardiovascular |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the Magic WALLSTENT(R) Endoprosthesis. This device is indicated for improving coronary luminal diameter in the following: 1) patients with symptomatic ischemic disease due to discreter de novo lesions in native coronary arteries (length <35mm) with a reference vessel diameter of 3.0 to 5.5mm; 2) treatment of abrupt or threatened closure in patients with failed interventional therapy in lesions with reference diameters in the range of 3.0 to 5.5mm. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 S013 |