# P990034: Medtronic Isomed Infusion System

- Pathway: PMA
- Applicant: Medtronic, Inc.
- Decided: Jul 21, 2000 after 389 days
- Product code: LKK (Pump, Infusion, Implanted, Programmable)
- Device class: 3
- Recalls of this device: 15 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Jan 14, 2011 · Not classified · Z-1061-2011: This letter provides important reminders concerning the potential for a pocket fill during a SynchroMed II or SynchroMed EL implantable drug pump refill procedure, and important patient management rec
- Feb 4, 2008 · Not classified · Z-1903-2008: Medtronic is retrieving all unused packages of ISOMED Refill Kit Model 8553, Lot 60538731. This lot of product was released using incorrect endotoxin specification limits. Endotoxin contamination can 
- Jan 16, 2008 · Not classified · Z-1153-2008: Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass format
- Jan 16, 2008 · Not classified · Z-1146-2008: Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass format
- Jan 16, 2008 · Not classified · Z-1149-2008: Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass format
- Jan 16, 2008 · Not classified · Z-1147-2008: Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass format
- Jan 16, 2008 · Not classified · Z-1144-2008: Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass format
- Jan 16, 2008 · Not classified · Z-1148-2008: Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass format
- Jan 16, 2008 · Not classified · Z-1151-2008: Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass format
- Jan 16, 2008 · Not classified · Z-1150-2008: Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass format
- Jan 16, 2008 · Not classified · Z-1142-2008: Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass format
- Jan 16, 2008 · Not classified · Z-1152-2008: Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass format
- Jan 16, 2008 · Not classified · Z-1145-2008: Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass format
- Jan 16, 2008 · Not classified · Z-1143-2008: Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass format
- Jan 16, 2008 · Not classified · Z-1154-2008: Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass format

Source page: https://510kreport.com/device/P990034
Methodology: https://510kreport.com/methodology