Premarket Approval (PMA)

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.

• Device: INTERPORE PRO OSTEON IMPLANT 500 CORALLINE HYDROXYAPATITE BONE VOID FILLER
• Generic Name: Filler, bone void, non-osteoinduction
• Applicant: Interpore Intl.; 181 Technology Dr.; Irvine, CA 92618
• PMA Number: P860005
• Supplement Number: S001
• Date Received: 02/08/1993
• Decision Date: 03/17/1994
• Reclassified Date: 06/02/2003
• Product Code: MBS
• Advisory Committee: Orthopedic
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No