PMA P800036S035

Device: INFUSAID IMPLANTABLE INFUSION PUMP
Applicant: Intera Oncology
PMA number: P800036
Supplement: S035
Product code: LKK
Decision date: 1997-12-19
Generic name: Pump, infusion, implanted, programmable
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.

Current openFDA PMA Record#

Device: INFUSAID IMPLANTABLE INFUSION PUMP
Applicant: Intera Oncology
PMA number: P800036
Supplement: S035
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 1997-12-19
Decision code: APPR
Date received: 1997-10-21
Supplement type: Normal 180 Day Track
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
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.