FDA.reportPublic FDA data

PMA P140032S053

Device
Implantable System for Remodulin
Applicant
Medtronic, Inc.
PMA number
P140032
Supplement
S053
Product code
LKK
Decision date
2020-05-08
Generic name
Pump, infusion, implanted, programmable
Approval order statement
Change to modify the procedure for the assessment of device bioburden at Medtronic's final device manufacturing facilities-Medtronic Puerto Rico Operations Company, located in Juncos, Puerto Rico .The change also requested other related administrative changes which update the procedure.

Current openFDA PMA Record#

Device
Implantable System for Remodulin
Applicant
Medtronic, Inc.
PMA number
P140032
Supplement
S053
Product code
LKK
Generic name
Pump, infusion, implanted, programmable
Decision date
2020-05-08
Decision code
OK30
Date received
2020-04-09
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change to modify the procedure for the assessment of device bioburden at Medtronic's final device manufacturing facilities-Medtronic Puerto Rico Operations Company, located in Juncos, Puerto Rico .The change also requested other related administrative changes which update the procedure.