PMA P050053S022

Device
INFUSE BONE GRAFT
Applicant
Medtronic, Inc.
PMA number
P050053
Supplement
S022
Product code
NPZ
Decision date
2012-10-17
Classification
Bone Grafting Material, Dental, With Biologic Component
Generic name
Bone grafting material, dental, with biologic component
Approval order statement
APPROVAL FOR CHANGE IN RESIN USAGE LIFETIME.

Current openFDA PMA Record#

Device
INFUSE BONE GRAFT
Applicant
Medtronic, Inc.
PMA number
P050053
Supplement
S022
Product code
NPZ
Generic name
Bone grafting material, dental, with biologic component
Decision date
2012-10-17
Decision code
APPR
Date received
2011-06-16
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR CHANGE IN RESIN USAGE LIFETIME.