PMA P050053S069

Device: Infuse™ Bone Graft
Applicant: Medtronic, Inc.
PMA number: P050053
Supplement: S069
Product code: NPZ
Decision date: 2026-07-28
Classification: Dental
Generic name: Bone grafting material, dental, with biologic component
Approval order statement: Approval to offer an alternatively configured Infuse™ Bone Graft kit in which the sterile water for injection (sWFI) vials, syringes, and needles have been removed from the kit, as well as minor labeling changes associated with this alternative kit configuration.

Current openFDA PMA Record#

Device: Infuse™ Bone Graft
Applicant: Medtronic, Inc.
PMA number: P050053
Supplement: S069
Product code: NPZ
Generic name: Bone grafting material, dental, with biologic component
Decision date: 2026-07-28
Decision code: APPR
Date received: 2026-04-29
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval to offer an alternatively configured Infuse™ Bone Graft kit in which the sterile water for injection (sWFI) vials, syringes, and needles have been removed from the kit, as well as minor labeling changes associated with this alternative kit configuration.