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 | CONSTANT FLOW IMPLANTABLE INFUSION PUMP |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | Intera Oncology 180 Wells Ave, Suite 300A Newton, MA 02459 |
PMA Number | P890055 |
Supplement Number | S009 |
Date Received | 02/23/1999 |
Decision Date | 01/21/2000 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for adding the Drug Lioresal (Baclofen) to the list of drugs approved for use with the Model 3000-16 and Model 3000-50 Implantable Drug Delivery Pumps. Also, the label will clearly indicate that baclofen is stable for 44 days at 37C. |
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