Serial Number NGV526743H

General Hospital and Personal Use Devices

3

Yes

IL

SynchroMed II implantable drug infusion pump, Model 8637-40,

Model 8627-10, serial numbers: NGE000001 - NGE000242R .  Model 8627-18, serial numbers: NGF000001 - NGF003266R.  Model 8627L-10, serial numbers: NGG000001R - NGG000068R,  Model 8627L-18, serial numbers: NGH000001R - NGH001780R.

General Hospital and Personal Use Devices

3

Yes

Worldwide distribution ---- including USA, Argentina, Barbados, Canada, Germany, India, Ireland, Italy, Mexico, The Netherlands, Spain, Switzerland, and United Kingdom.

Medtronic SynchroMed EL Programmable Pumps, Models 8627-10, 8627-18, 8627L-10, 8627L-18. The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories.

General Hospital and Personal Use Devices

Yes

Active implantable medical devices

General Hospital and Personal Use Devices

Yes

Active implantable medical devices - drug pumps

General Hospital and Personal Use Devices

Yes

Active implantable medical devices - drug pumps

General Hospital and Personal Use Devices

Yes

Active implantable medical devices - drug pumps

Yes

Active implantable medical devices

Yes

Active implantable medical devices

Yes

Active implantable medical devices

Yes

Active implantable medical devices

Yes

Active implantable medical devices - drug pumps

Yes

Active implantable medical devices - drug pumps

Yes

Active implantable medical devices - drug pumps

Yes

Active implantable medical devices - drug pumps

Yes

Active implantable medical devices - drug pumps

Yes

Active implantable medical devices - drug pumps

Yes

Active implantable medical devices - drug pumps

Yes

Active implantable medical devices - drug pumps

Yes

Active implantable medical devices - drug pumps

General Hospital and Personal Use Devices

Yes

Active implantable medical devices

Yes

Active implantable medical devices

Yes

Active implantable medical devices

General Hospital and Personal Use Devices

Yes

Active implant

Yes

Active implant

Yes

Active implant