PMA P900039

Device: COLLAGRAFT STRIP BONE GRAFT MATRIX
Applicant: Neucoll, Inc.
PMA number: P900039
Supplement: S015
Product code: MBS
Decision date: 2005-01-24
Generic name: Filler, bone void, non-osteoinduction
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.

Current openFDA PMA Record#

Device: COLLAGRAFT STRIP BONE GRAFT MATRIX
Applicant: Neucoll, Inc.
PMA number: P900039
Supplement: S015
Product code: MBS
Generic name: Filler, bone void, non-osteoinduction
Decision date: 2005-01-24
Decision code: OK30
Date received: 2004-12-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
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.