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. |
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Device | COLLAGRAFT STRIP BONE GRAFT MATRIX |
Generic Name | Filler, bone void, non-osteoinduction |
Applicant | NEUCOLL, INC. 105 COOPER CT. LOS GATOS, CA 95032-7604 |
PMA Number | P900039 |
Supplement Number | S015 |
Date Received | 12/27/2004 |
Decision Date | 01/24/2005 |
Reclassified Date
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06/02/2003 |
Product Code |
MBS |
Advisory Committee |
Orthopedic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE IN THE FINAL PRODUCT TESTING FROM RABBIT PYROGENICITY TEST TO A LIMULUS AMEBOCYTE LYSATE (LAL) GEL-CLOT TEST FOR DETERMINING THE PRESENCE OF ENDOTOXINS. |
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