PMA P800036S034

Device: INFUSAID IMPLANTABLE INFUSION PUMP
Applicant: Intera Oncology
PMA number: P800036
Supplement: S034
Product code: LKK
Decision date: 1997-12-19
Generic name: Pump, infusion, implanted, programmable
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.

Current openFDA PMA Record#

Device: INFUSAID IMPLANTABLE INFUSION PUMP
Applicant: Intera Oncology
PMA number: P800036
Supplement: S034
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 1997-12-19
Decision code: APPR
Date received: 1997-09-04
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
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.