PMA P050053S055

Device
Infuse Bone Graft
Applicant
Medtronic, Inc.
PMA number
P050053
Supplement
S055
Product code
NPZ
Decision date
2021-02-08
Generic name
Bone grafting material, dental, with biologic component
Approval order statement
Change to the process for printing and inspecting labels.

Current openFDA PMA Record#

Device
Infuse Bone Graft
Applicant
Medtronic, Inc.
PMA number
P050053
Supplement
S055
Product code
NPZ
Generic name
Bone grafting material, dental, with biologic component
Decision date
2021-02-08
Decision code
OK30
Date received
2021-01-15
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change to the process for printing and inspecting labels.