PMA P860004S118

Device
MEDTRONIC SYNCHROMEDPUMP AND INFUSION SYSTEM
Applicant
Medtronic, Inc.
PMA number
P860004
Supplement
S118
Product code
LKK
Decision date
2010-03-05
Classification
Pump, Infusion, Implanted, Programmable
Generic name
Pump, infusion, implanted, programmable
Approval order statement
APPROVAL FOR UPDATING THE ¿DURING DISCHARGE¿ BATTERY SPECIFICATION FOR THE MEDTRONIC SYNCHROMED II DRUG PUMP MODEL 8637.

Current openFDA PMA Record#

Device
MEDTRONIC SYNCHROMEDPUMP AND INFUSION SYSTEM
Applicant
Medtronic, Inc.
PMA number
P860004
Supplement
S118
Product code
LKK
Generic name
Pump, infusion, implanted, programmable
Decision date
2010-03-05
Decision code
APPR
Date received
2010-01-06
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR UPDATING THE ¿DURING DISCHARGE¿ BATTERY SPECIFICATION FOR THE MEDTRONIC SYNCHROMED II DRUG PUMP MODEL 8637.