MEDSTREAM PROGRAMMABLE INFUSION SYSTEM CODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP
FDA premarket approval P890055/S047 · decided 2013-01-16
Approval details
- PMA number
- P890055
- Supplement
- S047
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDSTREAM PROGRAMMABLE INFUSION SYSTEM CODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 2012-11-07
- Decision date
- 2013-01-16
- 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 CHANGE TO THE EPIDURAL FILTER COMPONENT OF THE MEDSTREAM REFILL AND BOLUS KIT, OPERATING ROOM (O.R.) PREP KIT, AND INSTRASPINAL CATHETER KIT.
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