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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NamePRO OSTEON IMPLANT 500 CORALLINE HYDROXYPATITE BONE VOID FILLER (FORMERLY INTERPORE 500)
Classification Namefiller, bone void, non-osteoinduction
Generic Namebone graft non-osteogenic
ApplicantINTERPORE INTL.
PMA NumberP860005
Supplement NumberS008
Date Received08/28/1997
Decision Date09/11/1997
Product Code
MBS[ Registered Establishments with MBS ]
Advisory Committee Physical Medicine
Supplement Typenormal 180 day track
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
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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