PMA P050053S057

Device
INFUSE™ Bone Graft
Applicant
Medtronic, Inc.
PMA number
P050053
Supplement
S057
Product code
NPZ
Decision date
2022-02-18
Generic name
Bone grafting material, dental, with biologic component
Approval order statement
Change in the packaging suppliers machine equipment.

Current openFDA PMA Record#

Device
INFUSE™ Bone Graft
Applicant
Medtronic, Inc.
PMA number
P050053
Supplement
S057
Product code
NPZ
Generic name
Bone grafting material, dental, with biologic component
Decision date
2022-02-18
Decision code
OK30
Date received
2022-01-20
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change in the packaging suppliers machine equipment.