PMA P990034

Device: IsoMed Infusion System
Applicant: Medtronic, Inc.
PMA number: P990034
Supplement: S043
Product code: LKK
Decision date: 2024-11-22
Generic name: Pump, infusion, implanted, programmable
Approval order statement: approval for updates to the Magnetic Resonance Imaging (MRI) Guidelines for the SynchroMed II in the labeling for SynchroMed and IsoMed infusion systems

Current openFDA PMA Record#

Device: IsoMed Infusion System
Applicant: Medtronic, Inc.
PMA number: P990034
Supplement: S045
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 2024-11-22
Decision code: APPR
Date received: 2024-10-25
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for updates to the Magnetic Resonance Imaging (MRI) Guidelines for the SynchroMed II in the labeling for SynchroMed and IsoMed infusion systems