INFUSE BONE GRAFT
FDA premarket approval P050053/S001 · decided 2008-03-06
Approval details
- PMA number
- P050053
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INFUSE BONE GRAFT
- Generic name
- Bone grafting material, dental, with biologic component
- Applicant
- Medtronic, Inc.
- Date received
- 2007-03-19
- Decision date
- 2008-03-06
- Days to decision
- 353 days
- Decision code
- APPR
- Product code
- NPZ
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FOR THE ADDITION OF THE XS AND XXS INFUSE BONE GRAFT KITS TO THE APPROVED DENTAL BONE GRAFTING MATERIAL.
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