FDA.reportPublic FDA data

PMA P140032S057

Device
Implantable System for Remodulin
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 Implantable System for Remodulin.

Current openFDA PMA Record#

Device
Implantable System for Remodulin
Applicant
Medtronic, Inc.
PMA number
P140032
Supplement
S057
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 Implantable System for Remodulin.