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 |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | Intera Oncology 65 William Street Suite 2000 Wellesley, MA 02481 |
PMA Number | P800036 |
Supplement Number | S034 |
Date Received | 09/04/1997 |
Decision Date | 12/19/1997 |
Withdrawal Date
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03/12/2021 |
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 the use of Arrow 22 gauge non-coring (hubber) needles (Catalog #s AP-04009, AP-04011, and AP-04030) to access Infusaid Model 400 infusion pumps. |
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