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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 Namefiller, bone void, non-osteoinduction
Generic Namecollagen/hydroxyapatite bone graft substitute
ApplicantNEU COLL
PMA NumberP900039
Supplement NumberS012
Date Received09/12/2002
Decision Date10/10/2002
Product Code
MBS[ Registered Establishments with MBS ]
Advisory Committee Physical Medicine
Supplement Type30-day notice
Supplement Reason process change: sterilization
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.