PMA P890055S031

Device: MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
Applicant: Intera Oncology
PMA number: P890055
Supplement: S031
Product code: LKK
Decision date: 2013-02-12
Classification: Pump, Infusion, Implanted, Programmable
Generic name: Pump, infusion, implanted, programmable
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE MEDSTREAM REFILL KIT AND O.R. PREP KIT. THE PMA SUPPLEMENT ALSO REQUESTED APPROVAL FOR STERILIZATION TO OCCUR AT STERIS ISOMEDIX SERVICES IN NORTHBOROUGH, MASSACHUSETTS AND KIT PACKAGING TO OCCUR AT CONTECH MEDICAL, INC., IN PROVIDENCE, RHODE ISLAND.

Current openFDA PMA Record#

Device: MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
Applicant: Intera Oncology
PMA number: P890055
Supplement: S031
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 2013-02-12
Decision code: APPR
Date received: 2011-01-18
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE MEDSTREAM REFILL KIT AND O.R. PREP KIT. THE PMA SUPPLEMENT ALSO REQUESTED APPROVAL FOR STERILIZATION TO OCCUR AT STERIS ISOMEDIX SERVICES IN NORTHBOROUGH, MASSACHUSETTS AND KIT PACKAGING TO OCCUR AT CONTECH MEDICAL, INC., IN PROVIDENCE, RHODE ISLAND.