PMA supplement
P050053 S035: INFUSE BONE GRAFT
FDA PMA supplement · Normal 180 Day Track · Medtronic, Inc.
Key facts
| Original PMA | P050053 |
|---|---|
| Supplement number | S035 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | INFUSE BONE GRAFT |
| Generic name | Bone grafting material, dental, with biologic component |
| Applicant | Medtronic, Inc. |
| Product code | NPZ |
| Received date | Jun 21, 2016 |
| Decision date | Sep 16, 2016 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: