FDA.reportPublic FDA data

PMA P050053S046

Device
Infuse Bone Graft
Applicant
Medtronic, Inc.
Product code
NPZ
Decision date
2019-12-16
Generic name
Bone grafting material, dental, with biologic component
Approval order statement
Approval for an additional configuration of the vials used for the sterile water for injection used to reconstitute the lyophilized rhBMP-2 component of Infuse Bone Graft.

Current openFDA PMA Record#

Device
Infuse Bone Graft
Applicant
Medtronic, Inc.
PMA number
P050053
Supplement
S046
Product code
NPZ
Generic name
Bone grafting material, dental, with biologic component
Decision date
2019-12-16
Decision code
APPR
Date received
2019-09-18
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for an additional configuration of the vials used for the sterile water for injection used to reconstitute the lyophilized rhBMP-2 component of Infuse Bone Graft.