PMA P890055S032
- Device
- MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S032
- Product code
- LKK
- Decision date
- 2011-05-10
- Classification
- Pump, Infusion, Implanted, Programmable
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- APPROVAL FOR A NEW ADHESIVE TO SECURE THE ANTENNA AND MODIFICATION TO THE PIEZO ACTUATOR RELEASE SPECIFICATION. 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 7.0 PH) IN THE TREATMENT OF SEVERE SPASTICITY.
Current openFDA PMA Record#
- Device
- MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S032
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2011-05-10
- Decision code
- APPR
- Date received
- 2011-03-01
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A NEW ADHESIVE TO SECURE THE ANTENNA AND MODIFICATION TO THE PIEZO ACTUATOR RELEASE SPECIFICATION. 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 7.0 PH) IN THE TREATMENT OF SEVERE SPASTICITY.