|
Device | NIR (TM) W/SOX PREMOUNTED STENT DELIVERY SYSTEM |
Applicant | Boston Scientific Corp. One Boston Scientific Place Natick, MA 01760 |
PMA Number | P980001 |
Supplement Number | S020 |
Date Received | 05/26/2000 |
Decision Date | 06/13/2000 |
Withdrawal Date
|
08/13/2007 |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE IN MANUFACTURING PROCESS TO REMOVE TWO INSPECTION STEPS FOR MARKERBAND PLACEMENT ON THE NIR(TM) W/SOX(TM) PREMOUNTED STENT DELIVERY SYSTEM. |