PMA P860004S064

Device: SYNCHROMED INFUSION SYSTEM
Applicant: Medtronic, Inc.
PMA number: P860004
Supplement: S064
Product code: LKK
Decision date: 2005-03-24
Classification: Pump, Infusion, Implanted, Programmable
Generic name: Pump, infusion, implanted, programmable
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE LABELING OF THE SYNCHROMED EL PUMPS TO INCREASE THE SHELF LIFE OF THE 10ML PUMPS TO 24 MONTHS AND THE 18ML PUMPS TO 48 MONTHS.

Current openFDA PMA Record#

Device: SYNCHROMED INFUSION SYSTEM
Applicant: Medtronic, Inc.
PMA number: P860004
Supplement: S064
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 2005-03-24
Decision code: APPR
Date received: 2004-12-16
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE LABELING OF THE SYNCHROMED EL PUMPS TO INCREASE THE SHELF LIFE OF THE 10ML PUMPS TO 24 MONTHS AND THE 18ML PUMPS TO 48 MONTHS.