INFUSE BONE GRAFT
FDA premarket approval P050053/S008 · decided 2008-05-13
Approval details
- PMA number
- P050053
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- INFUSE BONE GRAFT
- Generic name
- Bone grafting material, dental, with biologic component
- Applicant
- Medtronic, Inc.
- Date received
- 2008-02-19
- Decision date
- 2008-05-13
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- NPZ
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FOR LABELING MODIFICATIONS TO ADDRESS WARNINGS ABOUT IMPROPER PREPARATION OF INFUSE BONE GRAFT AND OVERFILLING OF BONE DEFECTS.
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