INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE
FDA premarket approval P000058/S048 · decided 2012-07-17
Approval details
- PMA number
- P000058
- Supplement
- S048
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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
- 2011-10-20
- Decision date
- 2012-07-17
- Days to decision
- 271 days
- Decision code
- APPR
- Product code
- NEK
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FOR MODIFICATIONS TO THE LABELING FOR THE IDENTIFIED PRODUCTS.SPECIFICALLY REQUESTED WAS THE FOLLOWING: 1) AN ADDITIONAL WARNING TO ADDRESS CONCERNS RELATED TO THE USE OF POTENTIAL PATIENTS WITH A SUSPECTED MALIGNANCY; 2) AN ADDITIONAL WARNING RELATED TO DEVICE MIGRATION; 3) A MODIFICATION TO THE PRECAUTION RELATED TO ECTOPIC, HETEROTOPIC AND EXUBERANT BONE FORMATION BY REMOVING THE INITIAL QUALIFYING LANGUAGE: AND 4) A MODIFICATION TO THE DESCRIPTION OF THE RECONSTITUTED RECOMBINANT PR
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