|
Device | WALLSTENT TIPS ENDOPROSTHESIS |
Generic Name | SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS |
Applicant | Boston Scientific Corp. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P930031 |
Supplement Number | S017 |
Date Received | 08/14/2003 |
Decision Date | 09/11/2003 |
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 STERILIZATION PARAMETERS FROM 50 DEGREES C PULSED CYCLE TO DART 50 DEGREES C CYCLE. |