FHC, Inc.

Software ver 1.4, Serial Numbers: 19454, 14423, 17349, 19215, 15573, 19424, 17583, 17589, 17588, and 17581. This version of software was released in August 2009

Neurological Devices

2

No

Worldwide Distribution -- USA, including states of GA, MA, NC, NJ, OH, RI, TN, TX, and WV and Bucharest, Romania.

FHC microTargeting Guideline 4000 ver 1.4 (GL4K) Software, || Catalog # MT-GL4K. || Intended to assist in functional neurological procedures.

Serial Numbers: 14511,16997, 15104  Medtronic: 15140,15108, 15084, 15081, 21380, 21375, 15153, 15107, 15118, 15098, 15092, 15071, 21372, 21389, 21386 Manufactured after January 21, 2010 and prior to March 22, 2010.

Neurological Devices

2

No

Worldwide distribution: USA in the states of AZ, CA, FL, ID, NC, MA, MI, MN, NV, RI, UT, VA, and WA, and countries of Columbia and South Africa.

microTargeting Drive System with Mounted Accessories || Catalog numbers : 66-ZD-MD-01, MT-DS-01, FC1006 (Medtronic) || Product is the FHC DBS Depth Stop Adapter, a component of the microTargeting Drive and the STar Drive. The Drives are intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the brain or nervous system.

Serial Numbers:  20640, 21292, 21182, 21276, 21267, 21183, 20605 Manufactured after January 21, 2010 and prior to March 22, 2010.

Neurological Devices

2

No

Worldwide distribution: USA in the states of AZ, CA, FL, ID, NC, MA, MI, MN, NV, RI, UT, VA, and WA, and countries of Columbia and South Africa.

STar Drive System, || Catalog numbers: ST-DS-MA, ST-DS-ME, 70-ZD-ME || Product is the FHC DBS Depth Stop Adapter, a component of the microTargeting Drive and the STar Drive. The Drives are intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the brain or nervous system.

Not serialized. Manufactured after January 21, 2010 and prior to March 22, 2010.

Neurological Devices

2

No

Worldwide distribution: USA in the states of AZ, CA, FL, ID, NC, MA, MI, MN, NV, RI, UT, VA, and WA, and countries of Columbia and South Africa.

microTargeting Drive DBS Lead Holder 66-CN-DB || Product is the FHC DBS Depth Stop Adapter, a component of the microTargeting Drive and the STar Drive. The Drives are intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the brain or nervous system.

Not serialized . Manufactured after January 21, 2010 and prior to March 22, 2010.

Neurological Devices

2

No

Worldwide distribution: USA in the states of AZ, CA, FL, ID, NC, MA, MI, MN, NV, RI, UT, VA, and WA, and countries of Columbia and South Africa.

Depth Stop Adapter 66-AC-DS(1.8), E6-01-.5 used with the microTargeting and STar Drives || Product is the FHC DBS Depth Stop Adapter, a component of the microTargeting Drive and the STar Drive. The Drives are intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the brain or nervous system.