Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | 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. 1800 Pyramid Place Memphis, TN 38132 |
PMA Number | P000058 |
Supplement Number | S007 |
Date Received | 03/04/2004 |
Decision Date | 03/30/2004 |
Product Code |
NEK |
Advisory Committee |
Orthopedic |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR A MODIFICATION TO THE PACKAGE INSERT. SPECIFICALLY, ADDING THE FOLLOWING ADDITIONAL EVENTS TO THE "POSSIBLE ADVERSE EVENTS" SECTION OF THE INSERT: "EDEMA (SWELLING), INFLAMMATION, ERYTHEMATOUS, ALLERGIC REACTION, DYSPHASIA, ITCHING, ANAPHYLACTIC REACTION, ELEVATED ERYTHROCYTE SEDIMENTATION RATE, PAIN, HEMATOMA." |
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