PMA P890055S056
- Device
- MEDSTREAM PROGRAMMABLE INFUSION PUMP
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S056
- Product code
- LKK
- Decision date
- 2014-07-30
- Classification
- Pump, Infusion, Implanted, Programmable
- Generic name
- Pump, infusion, implanted, programmable
- Approval order 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.
Current openFDA PMA Record#
- Device
- MEDSTREAM PROGRAMMABLE INFUSION PUMP
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S056
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2014-07-30
- Decision code
- APPR
- Date received
- 2014-05-01
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.