|
Device | WALLENSTENT TIPS ENDOPROSTHESIS |
Generic Name | SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS |
Applicant | Boston Scientific Corp. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P930031 |
Supplement Number | S020 |
Date Received | 12/08/2003 |
Decision Date | 01/07/2004 |
Product Code |
MIR |
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 THE MANUFACTURING PROCESS WHICH INVOLVED THE USE OF AN ALTERNATE BIOLOGICAL INDICATOR (BI) WITH A SHORTER LABELED INCUBATION TIME OF FOUR (4) HOURS FOR USE IN MONITORING THE EO STERILIZATION CYCLES AND STERILIZATION PROCESS VALIDATION. |