INFUSE BONE GRAFT
FDA premarket approval P050053/S025 · decided 2012-06-27
Approval details
- PMA number
- P050053
- Supplement
- S025
- Supplement type
- Special (Immediate 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
- 2012-05-16
- Decision date
- 2012-06-27
- Days to decision
- 42 days
- Decision code
- APPR
- Product code
- NPZ
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FOR THE PROPOSED LABELING REVISIONS RELATED TO THE APPEARANCE OF THE RECONSTITUTED PRODUCT AND WARNING STATEMENT ABOUT USE IN PATIENTS SUSPECTED OF HAVING CANCER AT THE PRODUCT APPLICATION SITE.
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