INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPPERED FUSION DEVICE
FDA premarket approval P000058/S019 · decided 2007-03-23
Approval details
- PMA number
- P000058
- Supplement
- S019
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPPERED FUSION DEVICE
- Generic name
- Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- Date received
- 2006-10-12
- Decision date
- 2007-03-23
- Days to decision
- 162 days
- Decision code
- APPR
- Product code
- NEK
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FOR MODIFICATIONS TO THE PACKAGE INSERTS AND PATIENT INFORMATION BROCHURES TO ADDRESS THE RESULTS OF THE REPRODUCTIVE TOXICITY STUDY SUBMITTED IN PMA REPORTS P000058/R23 AND P000054/R6.
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