PMA P900039S013

Device: NEUGRAFT
Applicant: Neucoll, Inc.
PMA number: P900039
Supplement: S013
Product code: MBS
Decision date: 2004-06-07
Generic name: Filler, bone void, non-osteoinduction
Approval order statement: APPROVAL FOR THE ADDITION OF THE PRODUCT "NEUGRAFT". COLLAGRAFT STRIP BONE GRAFT MATRIX (COLLAGRAFT) WAS ORIGINALLY APPROVED BY THE FDA ON JANUARY 27, 1994 (REVIEW OF P900039). THE PRODUCT CURRENTLY CONTINUES TO BE MARKETED BY THAT NAME. NEUGRAFT IS IDENTICAL TO COLLAGRAFT STRIP BONE GRAFT MATRIX, EXCEPT THAT THE BRAND NAME ON THE LABELING IS DIFFERENT. THE LABELING FOR NEUGRAFT INDICATED AND EXPLAINS THAT THE TWO PRODUCTS ARE THE SAME, BUT ARE SOLD THROUGH DIFFERENT DISTRIBUTION CHANNELS. AS PROPOSED, THE PRODUCT WILL CONTINUE TO BE SOLD USING BOTH NAMES COLLAGRAFT AND NEUGRAFT. THERE WILL BE NO CHANGE AFFECTING SAFETY AND EFFECTIVENESS FOR THIS PRODUCT.

Current openFDA PMA Record#

Device: NEUGRAFT
Applicant: Neucoll, Inc.
PMA number: P900039
Supplement: S013
Product code: MBS
Generic name: Filler, bone void, non-osteoinduction
Decision date: 2004-06-07
Decision code: APPR
Date received: 2004-04-30
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE ADDITION OF THE PRODUCT "NEUGRAFT". COLLAGRAFT STRIP BONE GRAFT MATRIX (COLLAGRAFT) WAS ORIGINALLY APPROVED BY THE FDA ON JANUARY 27, 1994 (REVIEW OF P900039). THE PRODUCT CURRENTLY CONTINUES TO BE MARKETED BY THAT NAME. NEUGRAFT IS IDENTICAL TO COLLAGRAFT STRIP BONE GRAFT MATRIX, EXCEPT THAT THE BRAND NAME ON THE LABELING IS DIFFERENT. THE LABELING FOR NEUGRAFT INDICATED AND EXPLAINS THAT THE TWO PRODUCTS ARE THE SAME, BUT ARE SOLD THROUGH DIFFERENT DISTRIBUTION CHANNELS. AS PROPOSED, THE PRODUCT WILL CONTINUE TO BE SOLD USING BOTH NAMES COLLAGRAFT AND NEUGRAFT. THERE WILL BE NO CHANGE AFFECTING SAFETY AND EFFECTIVENESS FOR THIS PRODUCT.