PMA P900039S010

Device: COLLAGRAFT STRIP BONE GRAFT MATRIX
Applicant: Neucoll, Inc.
PMA number: P900039
Supplement: S010
Product code: MBS
Decision date: 1998-12-07
Generic name: Filler, bone void, non-osteoinduction
Approval order statement: Approval for changes to your manufacturing process. These changes involve 1) moving some of the manufacturing operations currently performed in a Class 100 room to a "controlled" environment that provides the equivalent of a Class 10,000 environment, 2) increasing the "hold" time between the remisturization and irradiation processes, and 3) eliminating both the protein concentration assay for past homogenate mixing and the LAL pyrogenicity assay, as described in the supplement.

Current openFDA PMA Record#

Device: COLLAGRAFT STRIP BONE GRAFT MATRIX
Applicant: Neucoll, Inc.
PMA number: P900039
Supplement: S010
Product code: MBS
Generic name: Filler, bone void, non-osteoinduction
Decision date: 1998-12-07
Decision code: APPR
Date received: 1998-11-23
Supplement type: Real-Time Process
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for changes to your manufacturing process. These changes involve 1) moving some of the manufacturing operations currently performed in a Class 100 room to a "controlled" environment that provides the equivalent of a Class 10,000 environment, 2) increasing the "hold" time between the remisturization and irradiation processes, and 3) eliminating both the protein concentration assay for past homogenate mixing and the LAL pyrogenicity assay, as described in the supplement.