|
Device | NIR(TM) PREMOUNTED STENT SYSTEMS |
Applicant | Boston Scientific Corp. One Boston Scientific Place Natick, MA 01760 |
PMA Number | P980001 |
Supplement Number | S016 |
Date Received | 02/07/2000 |
Decision Date | 02/25/2000 |
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 The 30-day notice requested to increase the tolerance allowed in the stent overlap to markerband placement by 0.25 mm (from 0.25mm to 0.50mm) |