|
Device | CODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP |
Classification Name | pump, infusion, implanted, programmable |
Generic Name | pump, infusion, implanted, programmable |
Applicant |
CODMAN |
325 paramount dr. |
raynham, MA 02767 |
|
PMA Number | P890055 |
Supplement Number | S026 |
Date Received | 12/11/2007 |
Decision Date | 12/17/2010 |
Product Code | |
Advisory Committee |
General Hospital |
Supplement Type | normal 180 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product |
No
|
Approval Order Statement
APPROVAL FOR MEDSTREAM PROGRAMMABLE INFUSION SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDSTREAM PROGRAMMABLE INFUSION SYSTEM AND IS INDICATED FOR CHRONIC INTRATHECAL INFUSION OF BACLOFEN INJECTION STERILE SOLUTION (5.0 PH TO 7.0 PH) IN THE TREATMENT OF SEVERE SPASTICITY. |
Post-Approval Study | Show Report Schedule and Study Progress |