CODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP
FDA premarket approval P890055/S026 · decided 2010-12-17
Approval details
- PMA number
- P890055
- Supplement
- S026
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 2007-12-11
- Decision date
- 2010-12-17
- Days to decision
- 1102 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- 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.
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