|
Device | SYNCHROMED II INFUSION PUMP |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P860004 |
Supplement Number | S106 |
Date Received | 03/20/2009 |
Decision Date | 04/16/2009 |
Advisory Committee |
General Hospital |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement MODIFICATION TO THE METHOD FOR TRANSFERRING TEST DATA FROM THE OVER PRESSURE MECHANISM IN-PROCESS TEST INTO FACTORY WORKS. |