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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePRO OSTEON 500 POROUS HYDROXYAPATITE BONE GRAFT SUBSTITUE BLOCKS & GRANULES
Generic NameFiller, bone void, non-osteoinduction
ApplicantINTERPORE INTL.
181 TECHNOLOGY DR.
IRVINE, CA 92618-2402
PMA NumberP860005
Supplement NumberS011
Date Received04/22/1999
Decision Date05/25/1999
Reclassified Date 06/02/2003
Product Codes LMN MBS 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for updated labeling that reflects the results of the completed post-market approval study.
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