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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namespinal pedicle screw, fixation, appliance system
Generic Namespinal pedicle screw, fixation, appliance system
325 paramont drive
raynham, MA 02767
PMA NumberP960025
Supplement NumberS006
Date Received03/27/2001
Decision Date05/14/2001
Product Code
MCV[ Registered Establishments with MCV ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason other report
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following four changes to the investigational plan (ip) for the postapproval study: 1) the use of additional pedicle screw spinal systems with the i/f cage component, i. E. , to allow for th euse of the ti alloy version of the vsp spine system, the ti alloy and stainless steel versions of the isola spine system, the timx spine system and the ti alloy and stainless steel versions of the moss miami spine system in addition to the stainless steel version of the vsp spine system; 2) a change in the name of the device system to be evaluated in the postapproval study to be consistent with the recently approved device system name change; 3) a modification of the intra-op case report form to allow investigators to record which pedicle screw spinal system identified in item 1 above was actually implanted; and 4) a change to the required radiographic assessment methods, i. E. , the optional use of t1-weighted mri and discography.