PMA P100006S006

Device

AUGMENT Bone Graft and AUGMENT Injectable

Applicant

Biomimetic Therapeutics, LLC

PMA number

P100006

Supplement

S006

Product code

NOX

Decision date

2018-09-26

Classification

Filler, Bone Void, Synthetic Peptide

Generic name

Filler, bone void, synthetic peptide

Approval order statement

Approval for an alternate secondary packaging configuration for AUGMENT Injectable and corresponding changes in the AUGMENT Injectable package insert and surgical technique guide reflecting this alternate packaging configuration; re-design of the AUGMENT Injectable kit carton to accommodate a pouch in pouch configuration; and modifications to the payload area and the number of frozen gel packs utilized in the approved shipping unit for both AUGMENT Injectable and AUGMENT Bone Graft.

Summary

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