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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.
 
DeviceINTERPORE PRO OSTEAN(R)IMPLANT 500 COR. HYDROX
Generic NameFiller, bone void, non-osteoinduction
ApplicantInterpore Intl.
181 Technology Dr.
Irvine, CA 92618
PMA NumberP860005
Supplement NumberS002
Date Received03/23/1993
Decision Date11/17/1993
Reclassified Date06/02/2003
Product Code MBS 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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