FDA.reportPublic FDA data

PMA P140032S041

Device
Implantable System for Remodulin
Applicant
Medtronic, Inc.
PMA number
P140032
Supplement
S041
Product code
LKK
Decision date
2019-09-27
Classification
Pump, Infusion, Implanted, Programmable
Generic name
Pump, infusion, implanted, programmable
Approval order statement
Updates to the titanium dioxide paste specification as well as the receiving inspection procedure, allowing a new test method to be implemented and detect both aluminum oxide and titanium dioxide.

Current openFDA PMA Record#

Device
Implantable System for Remodulin
Applicant
Medtronic, Inc.
PMA number
P140032
Supplement
S041
Product code
LKK
Generic name
Pump, infusion, implanted, programmable
Decision date
2019-09-27
Decision code
OK30
Date received
2019-08-30
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Updates to the titanium dioxide paste specification as well as the receiving inspection procedure, allowing a new test method to be implemented and detect both aluminum oxide and titanium dioxide.