PMA P890055S033
- Device
- MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S033
- Product code
- LKK
- Decision date
- 2011-05-23
- Classification
- Pump, Infusion, Implanted, Programmable
- Generic name
- Pump, infusion, implanted, programmable
- Approval order 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 TO 7.0PH) IN THE TREATMENT OF SEVERE SPASTICITY.
Current openFDA PMA Record#
- Device
- MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S033
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2011-05-23
- Decision code
- APPR
- Date received
- 2011-01-28
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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 TO 7.0PH) IN THE TREATMENT OF SEVERE SPASTICITY.