INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE
FDA premarket approval P000058/S003 · decided 2003-06-24
Approval details
- PMA number
- P000058
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- 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
- 2002-12-16
- Decision date
- 2003-06-24
- Days to decision
- 190 days
- Decision code
- APPR
- Product code
- NEK
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY FOR ASSEMBLING AND PACKAGING THE PARTS OF THE INFUSE BONE GRAFT COMPONENT OF THE DEVICE. THE FACILITY IS LOCATED AT MEDTRONIC SOFAMOR DANEK USA, INC., MEMPHIS, TENNESEE.
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