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 SYSTEM |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | Intera Oncology 180 Wells Ave, Suite 300A Newton, MA 02459 |
PMA Number | P890055 |
Supplement Number | S039 |
Date Received | 03/16/2012 |
Decision Date | 04/30/2012 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CONTROL UNIT CIRCUITRY HARDWARE MODIFICATIONS WHICH INCLUDED POTENTIOMETER VALUE CHANGE, RESISTANCE VALUE CHANGE AND CAPACITOR TOLERANCE NARROWING. |
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