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 SELF-EXPANDING CORONARY STENT |
Generic Name | STENT, CORONARY |
Applicant | BOSTON SCIENTIFIC SCIMED, INC. TWO SCIMED PLACE MAPLE GROVE, MN |
PMA Number | P980009 |
Supplement Number | S003 |
Date Received | 01/19/1999 |
Decision Date | 02/17/1999 |
Withdrawal Date
|
09/28/2007 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for change to the Instructions for Use. |
|
|