FDA.reportPublic FDA data

PMA P860004S360

Device
SynchroMed Infusion System, Ascenda Intrathecal Catheters
Applicant
Medtronic, Inc.
Product code
LKK
Decision date
2020-09-22
Generic name
Pump, infusion, implanted, programmable
Approval order statement
Approval for change to improve the final product yield in the final pack manufacturing step to confirm telemetry of the SynchroMed II Implantable Infusion Pump Model 8637 for the SynchroMed Infusion System.

Current openFDA PMA Record#

Device
SynchroMed Infusion System, Ascenda Intrathecal Catheters
Applicant
Medtronic, Inc.
PMA number
P860004
Supplement
S360
Product code
LKK
Generic name
Pump, infusion, implanted, programmable
Decision date
2020-09-22
Decision code
APPR
Date received
2020-06-01
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for change to improve the final product yield in the final pack manufacturing step to confirm telemetry of the SynchroMed II Implantable Infusion Pump Model 8637 for the SynchroMed Infusion System.