INFUSE BONE GRAFT
FDA premarket approval P050053/S010 · decided 2010-01-20
Approval details
- PMA number
- P050053
- Supplement
- S010
- Supplement type
- 135 Review Track For 30-Day Notice
- Trade name
- INFUSE BONE GRAFT
- Generic name
- Bone grafting material, dental, with biologic component
- Applicant
- Medtronic, Inc.
- Date received
- 2008-11-21
- Decision date
- 2010-01-20
- Days to decision
- 425 days
- Decision code
- APPR
- Product code
- NPZ
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FOR AN ADDITIONAL SUPPLIER OF BOVINE ACHILLES TENDON FOR THE MANUFACTURE OF THE ABSORBABLE COLLAGEN SPONGE (ACS) COMPONENT OF THE INFUSE BONE GRAFT.
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