PMA P140032S013

Device: Implantable System for Remodulin
Applicant: Medtronic, Inc.
PMA number: P140032
Supplement: S013
Product code: LKK
Decision date: 2018-08-22
Classification: Pump, Infusion, Implanted, Programmable
Generic name: Pump, infusion, implanted, programmable
Approval order statement: Approval for a change to the XT038 TAZ series tantalum capacitor along with the required manufacturing and inspection procedure adjustments to accommodate the change.

Current openFDA PMA Record#

Device: Implantable System for Remodulin
Applicant: Medtronic, Inc.
PMA number: P140032
Supplement: S013
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 2018-08-22
Decision code: APPR
Date received: 2018-06-01
Supplement type: Real-Time Process
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a change to the XT038 TAZ series tantalum capacitor along with the required manufacturing and inspection procedure adjustments to accommodate the change.