MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
FDA premarket approval P890055/S033 · decided 2011-05-23
Approval details
- PMA number
- P890055
- Supplement
- S033
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 2011-01-28
- Decision date
- 2011-05-23
- Days to decision
- 115 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- Statement
- APPROVAL FOR SOFTWARE MODIFICATION TO THE MEDSTREAM PROGRAMMABLE INFUSION SYSTEM. THE MODIFIED MEDSTREAM PUMP WILL HAVE SOFTWARE PS-100044 VERSION 3.06, THE MODIFIED CONTROL UNIT WILL HAVE SOFTWARE PS-100046 VERSION 3.00. PS-100045 VERSION 3.04, PS-1000047 VERSION 3.09 AND PS-100021 VERSION 2.00. THE DEVICE,AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDSTREAM PROGRAMMABLE INFUSION SYSTEM AND IS INDICATED FOR THE CHRONIC INTRATHECAL INFUSION OF BACLOFEN INJECTION STERILE SOLUTION (5.0 PH
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