Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | MEDSTREAM PROGRAMMABLE INFUSION PUMP |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | Intera Oncology 180 Wells Ave, Suite 300A Newton, MA 02459 |
PMA Number | P890055 |
Supplement Number | S056 |
Date Received | 05/01/2014 |
Decision Date | 07/30/2014 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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. |
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