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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.
 
DeviceCOLLAGRAFT STRIP BONE GRAFT MATRIX
Classification Namefiller, bone void, non-osteoinduction
Generic Namefiller, bone void, non-osteoinduction
Applicant
NEUCOLL, INC.
105 cooper ct.
los gatos, CA 95032-7604
PMA NumberP900039
Supplement NumberS012
Date Received09/12/2002
Decision Date10/10/2002
Product Code
MBS[ Registered Establishments with MBS ]
Advisory Committee Orthopedic
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
CHANGE IN THE DEFINITION OF A SAMPLE ITEM PORTION (SIP) FROM A STRIP ALONE TO A STRIP PLUS INNER PACKAGING (INNER TRAY, INNER TRAY LID, LIFT TAB, AND TRAY RETAINER). ONLY A SINGLE SIP MAY BE SOURCED FROM EACH TRAY.
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