|
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 | S034 |
Date Received | 05/25/2011 |
Decision Date | 06/21/2011 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL TO ADD A WARNING STATEMENT TO THE INSTRUCTIONS FOR USE. |