MEDSTREAM PROGRAMMABLE INFUSION PUMP
FDA premarket approval P890055/S056 · decided 2014-07-30
Approval details
- PMA number
- P890055
- Supplement
- S056
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDSTREAM PROGRAMMABLE INFUSION PUMP
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 2014-05-01
- Decision date
- 2014-07-30
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- Statement
- APPROVAL TO REPLACE ELECTRICAL GAP WELDING OR LASER WELDING OF THE MEDSTREAM PUMP¿S ELECTRICAL COMPONENTS ON THE PRINTED CIRCUIT BOARD (PCB) WITH A THERMOBRAZING PROCESS, MODIFY THE EXTREMITY OF THE FLEX FLS, FLEX RF, AND BATTERY RIBBON COMPONENT TO INCLUDE APERTURES, AND ELIMINATE THE CURRENT IN-PROCESS MICRO PULL TEST FOR EACH CONNECTION.
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