|
Device | MEDSTREAM PROGRAMMABLE INFUSION SYSTEM |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | Intera Oncology 180 Wells Ave, Suite 300A Newton, MA 02459 |
PMA Number | P890055 |
Supplement Number | S035 |
Date Received | 09/30/2011 |
Decision Date | 01/05/2012 |
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 AN ALTERNATE SUPPLIER FOR THE PASSIVATION OF COMPONENTS NEEDED TO MANUFACTURE ACCESSORIES USED WITH THE CODMAN 3000 SERIES CONSTANT FLOW IMPLANTABLE INFUSION PUMP AND MEDSTREAM PROGRAMMABLE INFUSION PUMP. |