|
Device | NEXSTENT CAROTID STENT & MONORAIL DELIVERY SYSTEM |
Generic Name | STENT, CAROTID |
Applicant | BOSTON SCIENTIFIC ONE SCIMED PLACE MS A350 MAPLE GROVE, MN 55311-1566 |
PMA Number | P050025 |
Supplement Number | S008 |
Date Received | 03/10/2008 |
Decision Date | 04/09/2008 |
Product Code |
NIM |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ESTABLISHMENT OF A NEW TEST TO THE INSPECTION OF INCOMING SUBASSEMBLIES. |