|
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 | S035 |
Date Received | 10/21/1997 |
Decision Date | 12/19/1997 |
Withdrawal Date
|
03/12/2021 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for packaging and sterilizing the Arrow 22 gauge non-coring needle inside the Strato/Infusaid Refill Kit (#103381) in addition to the individually packaged sterile needle configuration. |