INFUSE BONE GRAFT
FDA premarket approval P050053/S015 · decided 2014-07-24
Approval details
- PMA number
- P050053
- Supplement
- S015
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INFUSE BONE GRAFT
- Generic name
- Bone grafting material, dental, with biologic component
- Applicant
- Medtronic, Inc.
- Date received
- 2010-05-14
- Decision date
- 2014-07-24
- Days to decision
- 1532 days
- Decision code
- APPR
- Product code
- NPZ
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT WYETH FARMA, S.A, IN DE LOS REYES, SPAIN.
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| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
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