Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | MEDSTREAM PROGRAMMABLE INFUSION SYSTEM, 91-4200US, 91-4201US, 91-4205US |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | Intera Oncology 180 Wells Ave, Suite 300A Newton, MA 02459 |
PMA Number | P890055 |
Supplement Number | S045 |
Date Received | 09/13/2012 |
Decision Date | 10/12/2012 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO ADD GABLOFEN INTRATHECAL TO THE LIST OF APPROVED DRUGS IN THE INSTRUCTIONS FOR USE. 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 IN THE TREATMENT OF SEVERE SPASTICITY. |
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