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 | IMPLANTABLE INFUSION PUMPS |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | Intera Oncology 180 Wells Ave, Suite 300A Newton, MA 02459 |
PMA Number | P890055 |
Supplement Number | S015 |
Date Received | 06/21/2002 |
Decision Date | 09/24/2002 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE TO THE LABELING TO ADD A MAGNETIC RESONANCE IMAGING (MRI) COMPATIBILITY STATEMENT. ONE LABEL IS A MRI DATA CHART AND ONE LABEL IS A TECHNICAL REPORT DESCRIBING THE EFFECTS OF MRI ON THE DEVICE. |
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