MEDSTREAM PROGRAMMABLE INFUSION SYSTEM, 91-4200US, 91-4201US, 91-4205US
FDA premarket approval P890055/S045 · decided 2012-10-12
Approval details
- PMA number
- P890055
- Supplement
- S045
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MEDSTREAM PROGRAMMABLE INFUSION SYSTEM, 91-4200US, 91-4201US, 91-4205US
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 2012-09-13
- Decision date
- 2012-10-12
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- 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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