|
Device | SYNCHROMED II INFUSION PUMP |
Generic Name | pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 central avenue ne minneapolis, MN 55432-3576 |
PMA Number | P860004 |
Supplement Number | S151 |
Date Received | 05/13/2011 |
Decision Date | 01/13/2012 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | 135 review track for 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING CHANGE RELATED TO THE DESICCANT INSPECTION STEP FOR THE SYNCHROMED II INFUSION PUMP, MODEL 8637. |