PMA P860004S063

Device: MEDTRONIC SYNCHROMED II IMPLANTABLE PROGRAMMABLE INFUSION PUMP SYSTEM
Applicant: Medtronic, Inc.
PMA number: P860004
Supplement: S063
Product code: LKK
Decision date: 2004-11-12
Classification: Pump, Infusion, Implanted, Programmable
Generic name: Pump, infusion, implanted, programmable
Approval order statement: UPDATING THE FINAL FUNCTIONAL TEST SOFTWARE TO REDUCE HUMAN DATA ENTRY ERRORS AND ADDING AN ADDITIONAL EQUIPMENT INTERFACE TO AVOID CALIBRATION CONSTANT ENTRY ERRORS BY MANUFACTURING OPERATORS.

Current openFDA PMA Record#

Device: MEDTRONIC SYNCHROMED II IMPLANTABLE PROGRAMMABLE INFUSION PUMP SYSTEM
Applicant: Medtronic, Inc.
PMA number: P860004
Supplement: S063
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 2004-11-12
Decision code: OK30
Date received: 2004-10-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: UPDATING THE FINAL FUNCTIONAL TEST SOFTWARE TO REDUCE HUMAN DATA ENTRY ERRORS AND ADDING AN ADDITIONAL EQUIPMENT INTERFACE TO AVOID CALIBRATION CONSTANT ENTRY ERRORS BY MANUFACTURING OPERATORS.