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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 POROUS CORALLINE HYDROXYAPATITE BONE GRAFT SUBSTITUTE
Generic NameFiller, bone void, non-osteoinduction
ApplicantInterpore Intl.
181 Technology Dr.
Irvine, CA 92618
PMA NumberP860005
Supplement NumberS010
Date Received11/18/1997
Decision Date01/08/1998
Reclassified Date06/02/2003
Product Code MBS 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a change to the name of the product from "Bone Void Filler" to "Bone Graft Substitute." The device, as modified in designation, will be marketed under the trade name "Pro Osteon Implant 500 Porous Coralline Hydroxyapatite Bone Graft Substitute Blocks and Granules," and is indicated for the same indications approved in the original PMA and in P860006/S002.
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