FDA.reportPublic FDA data

PMA P140032S069

Device
Implantable System for Remodulin
Applicant
Medtronic, Inc.
PMA number
P140032
Supplement
S069
Product code
LKK
Decision date
2021-05-03
Generic name
Pump, infusion, implanted, programmable
Approval order statement
Implementation of a new Servo Press machine at Brunk Industries, Inc to manufacture the SynchroMed II Pump (SMII) Inner Shield (P/N M955170A001) for the SynchroMed Infusion System.

Current openFDA PMA Record#

Device
Implantable System for Remodulin
Applicant
Medtronic, Inc.
PMA number
P140032
Supplement
S069
Product code
LKK
Generic name
Pump, infusion, implanted, programmable
Decision date
2021-05-03
Decision code
OK30
Date received
2021-04-08
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implementation of a new Servo Press machine at Brunk Industries, Inc to manufacture the SynchroMed II Pump (SMII) Inner Shield (P/N M955170A001) for the SynchroMed Infusion System.