PMA P900039S011

Device: COLLAGRAFT STRIP BONE GRAFT MATRIX
Applicant: Neucoll, Inc.
PMA number: P900039
Supplement: S011
Product code: MBS
Decision date: 2002-07-02
Generic name: Filler, bone void, non-osteoinduction
Approval order statement: APPROVAL FOR ADDITION MANUFACTURING SITES LOCATED AT: BIOSERV CORPORATION, SAN DIEGO, CALIFORNIA; BIOLOGICAL TEST CENTER, B. BRAUN MEDICAL, INC., IRVINE, CALIFORNIA; NEUCOLL, INC., CAMBELL, CALIFORNIA; AND PHARMACEUTICAL SYSTEMS, INC., MUNDALEIN, ILLINOIS.

Current openFDA PMA Record#

Device: COLLAGRAFT STRIP BONE GRAFT MATRIX
Applicant: Neucoll, Inc.
PMA number: P900039
Supplement: S011
Product code: MBS
Generic name: Filler, bone void, non-osteoinduction
Decision date: 2002-07-02
Decision code: APPR
Date received: 2001-09-19
Supplement type: Normal 180 Day Track
Supplement reason: Express GMP Supplement
Approval order statement: APPROVAL FOR ADDITION MANUFACTURING SITES LOCATED AT: BIOSERV CORPORATION, SAN DIEGO, CALIFORNIA; BIOLOGICAL TEST CENTER, B. BRAUN MEDICAL, INC., IRVINE, CALIFORNIA; NEUCOLL, INC., CAMBELL, CALIFORNIA; AND PHARMACEUTICAL SYSTEMS, INC., MUNDALEIN, ILLINOIS.