PMA P890055S055

Device: MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
Applicant: Intera Oncology
PMA number: P890055
Supplement: S055
Product code: LKK
Decision date: 2014-05-22
Classification: Pump, Infusion, Implanted, Programmable
Generic name: Pump, infusion, implanted, programmable
Approval order statement: APPROVAL FOR CHANGES TO QUALITY CONTROL AND MANUFACTURING PROCEDURES TO INCLUDE ADDITIONAL STEPS VERIFYING THAT A MINIMUM OF 66 HOURS HAVE ELAPSED BETWEEN THE TIME THAT THE MEDSTREAM PUMP BATTERY IS CONNECTED TO THE PRINTED CIRCUIT BOARD (PCB) AND BEFORE PROGRAMMING THE PCB WITH THE PRODUCTION DIAGNOSTIC PUMP SOFTWARE.

Current openFDA PMA Record#

Device: MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
Applicant: Intera Oncology
PMA number: P890055
Supplement: S055
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 2014-05-22
Decision code: APPR
Date received: 2014-04-28
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR CHANGES TO QUALITY CONTROL AND MANUFACTURING PROCEDURES TO INCLUDE ADDITIONAL STEPS VERIFYING THAT A MINIMUM OF 66 HOURS HAVE ELAPSED BETWEEN THE TIME THAT THE MEDSTREAM PUMP BATTERY IS CONNECTED TO THE PRINTED CIRCUIT BOARD (PCB) AND BEFORE PROGRAMMING THE PCB WITH THE PRODUCTION DIAGNOSTIC PUMP SOFTWARE.