FDA.reportPublic FDA data

PMA P140032S054

Device
Implantable System for Remodulin
Applicant
Medtronic, Inc.
PMA number
P140032
Supplement
S054
Product code
LKK
Decision date
2020-05-14
Generic name
Pump, infusion, implanted, programmable
Approval order statement
SynchroMed II Implantable Infusion Pump and Implantable System for Remodulin the creation of new supplier tooling, automation of an existing supplier test system, and modification of supporting component and device drawings for component assemblies.

Current openFDA PMA Record#

Device
Implantable System for Remodulin
Applicant
Medtronic, Inc.
PMA number
P140032
Supplement
S054
Product code
LKK
Generic name
Pump, infusion, implanted, programmable
Decision date
2020-05-14
Decision code
OK30
Date received
2020-04-16
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
SynchroMed II Implantable Infusion Pump and Implantable System for Remodulin the creation of new supplier tooling, automation of an existing supplier test system, and modification of supporting component and device drawings for component assemblies.