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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 92618-2402
PMA NumberP860005
Supplement NumberS008
Date Received08/28/1997
Decision Date09/11/1997
Reclassified Date 06/02/2003
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
Approval Order Statement  
Approval for a new sterilization site located at Isomedix Operations, Inc., Sand Utah Division, 9120 South 150 East, Sandy, UT.
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