FDA.reportPublic FDA data

PMA P000054S059

Device
Infuse Bone Graft
Applicant
Medtronic Sofamor Danek USA, Inc.
PMA number
P000054
Supplement
S059
Product code
MPW
Decision date
2020-07-10
Generic name
Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction
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 Sofamor Danek USA, Inc.
PMA number
P000054
Supplement
S059
Product code
MPW
Generic name
Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction
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.