INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE
FDA premarket approval P000058/S005 · decided 2004-12-27
Approval details
- PMA number
- P000058
- Supplement
- S005
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE
- Generic name
- Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- Date received
- 2003-08-22
- Decision date
- 2004-12-27
- Days to decision
- 493 days
- Decision code
- APPR
- Product code
- NEK
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FOR THE DRAFT PROTOCOL FOR THE RABBIT REPRO/TOX STUDY REQUIRED AS A CONDITIONS OF APPROVAL. THE PROPOSED STUDY IS DESIGNED TO EVALUATE THE IMPACT OF A MATERNAL IMMUNE RESPONSE ON THE DEVELOPMENT OF OFFSPRING. THIS IS DETERMINED VIA AN ASSESSMENT OF "ETAL MORTALITY, FETAL WEIGHT, AND FETAL PLACENTAL MORPHOLOGY
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