|
Device | NIROYAL(R) ELITE OVER-THE-WIRE STENT SYSTEM |
Applicant | Boston Scientific Corp. One Boston Scientific Place Natick, MA 01760 |
PMA Number | P980001 |
Supplement Number | S030 |
Date Received | 03/12/2001 |
Decision Date | 04/10/2001 |
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 EMODIFICATION TO THE ACCEPTANCE CRITERIA FOR THE GEL LUMP SIZE TO THE SOX(TM) COMPONENT FROM 0.005" TO <= 0.010". |