MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
FDA premarket approval P890055/S035 · decided 2012-01-05
Approval details
- PMA number
- P890055
- Supplement
- S035
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 2011-09-30
- Decision date
- 2012-01-05
- Days to decision
- 97 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- Statement
- APPROVAL FOR AN ALTERNATE SUPPLIER FOR THE PASSIVATION OF COMPONENTS NEEDED TO MANUFACTURE ACCESSORIES USED WITH THE CODMAN 3000 SERIES CONSTANT FLOW IMPLANTABLE INFUSION PUMP AND MEDSTREAM PROGRAMMABLE INFUSION PUMP.
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