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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 IMPLANT 500 CORALLINE HYDROXYPATITE BONE VOID FILLER (FORMERLY INTERPORE 500)
Generic NameFiller, bone void, non-osteoinduction
ApplicantInterpore Intl.
181 Technology Dr.
Irvine, CA 92618
PMA NumberP860005
Supplement NumberS007
Date Received05/15/1997
Decision Date05/30/1997
Reclassified Date06/02/2003
Product Code MBS 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS, INTERNATIONAL, 344 BONNIE CIRCLE, CORONA, CA.
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