MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
FDA premarket approval P890055/S048 · decided 2014-07-15
Approval details
- PMA number
- P890055
- Supplement
- S048
- Supplement type
- Special (Immediate Track)
- 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
- 2013-06-28
- Decision date
- 2014-07-15
- Days to decision
- 382 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- Statement
- APPROVAL FOR AN ADDITIONAL INSPECTION STEP IN THE MANUFACTURING PROCESS OF THE MEDSTREAM DEVICE TO REQUIRE A POST-STERILIZATION FILL LEVEL SENSOR (FLS) FUNCTIONAL INSPECTION.
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