FDA.reportPublic FDA data

PMA P140032S043

Device
Implantable System for Remodulin
Applicant
Medtronic, Inc.
PMA number
P140032
Supplement
S043
Product code
LKK
Decision date
2019-12-11
Generic name
Pump, infusion, implanted, programmable
Approval order statement
Update Medtronics manufacturing software, Manufacturing Execution System to Factory Works (Release 9.7), which is comprised of (1) FW Business Rule Client 9.7, (2) FW Configuration Client 9.2.2, and (3) Integrated Manufacturing Process Management (iMPM) Web Services (WS) 3.6.

Current openFDA PMA Record#

Device
Implantable System for Remodulin
Applicant
Medtronic, Inc.
PMA number
P140032
Supplement
S043
Product code
LKK
Generic name
Pump, infusion, implanted, programmable
Decision date
2019-12-11
Decision code
OK30
Date received
2019-11-15
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Update Medtronics manufacturing software, Manufacturing Execution System to Factory Works (Release 9.7), which is comprised of (1) FW Business Rule Client 9.7, (2) FW Configuration Client 9.2.2, and (3) Integrated Manufacturing Process Management (iMPM) Web Services (WS) 3.6.