MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
FDA premarket approval P890055/S032 · decided 2011-05-10
Approval details
- PMA number
- P890055
- Supplement
- S032
- 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
- 2011-03-01
- Decision date
- 2011-05-10
- Days to decision
- 70 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- 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.
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