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 | INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4 |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | Intera Oncology 65 William Street Suite 2000 Wellesley, MA 02481 |
PMA Number | P800036 |
Supplement Number | S013 |
Date Received | 12/10/1985 |
Decision Date | 11/04/1988 |
Withdrawal Date
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03/12/2021 |
Product Code |
LKK |
Docket Number | 82M-0072 |
Notice Date | 02/01/1989 |
Advisory Committee |
General Hospital |
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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