|
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 | S053 |
Date Received | 12/23/2013 |
Decision Date | 01/22/2014 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR ADDITION OF A 100% INSPECTION TO VERIFY THE USE BY DATE ON THE LABELS OF THE MEDSTREAM IMPLANTABLE INFUSION PUMP SYSTEM. |