PMA P100006S003

Device
AUGMENT BONE GRAFT
Applicant
Biomimetic Therapeutics, LLC
PMA number
P100006
Supplement
S003
Product code
NOX
Decision date
2016-10-06
Classification
Filler, Bone Void, Synthetic Peptide
Generic name
Filler, bone void, synthetic peptide
Approval order statement
Approval for termination of the New Enrollment Postapproval Study.

Current openFDA PMA Record#

Device
AUGMENT BONE GRAFT
Applicant
Biomimetic Therapeutics, LLC
PMA number
P100006
Supplement
S003
Product code
NOX
Generic name
Filler, bone void, synthetic peptide
Decision date
2016-10-06
Decision code
APPR
Date received
2015-09-30
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol - OSB
Approval order statement
Approval for termination of the New Enrollment Postapproval Study.