FDA.reportPublic FDA data

PMA P050053S050

Device
Infuse Bone Graft
Applicant
Medtronic, Inc.
PMA number
P050053
Supplement
S050
Product code
NPZ
Decision date
2020-07-10
Generic name
Bone grafting material, dental, with biologic component
Approval order statement
Optimization of the pre-sterilization phase set points of in-process autoclave cycles and addition of a second Tyvek wrapping for equipment, parts, and components sterilized in the in-process autoclaves.

Current openFDA PMA Record#

Device
Infuse Bone Graft
Applicant
Medtronic, Inc.
PMA number
P050053
Supplement
S050
Product code
NPZ
Generic name
Bone grafting material, dental, with biologic component
Decision date
2020-07-10
Decision code
OK30
Date received
2020-06-11
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Optimization of the pre-sterilization phase set points of in-process autoclave cycles and addition of a second Tyvek wrapping for equipment, parts, and components sterilized in the in-process autoclaves.