|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||INFUSE BONE GRAFT|
|Classification Name||bone grafting material, dental, with biologic component|
|Applicant|| MEDTRONIC INC.|
|Supplement Type||135 review track for 30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for an additional supplier of bovine achilles tendon for the manufacture of the absorbable collagen sponge (acs) component of the infuse bone graft.