INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE

FDA premarket approval P000058/S027 · decided 2008-03-21

Approval details

PMA number

P000058

Supplement

S027

Supplement type

Normal 180 Day Track No User Fee

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

2007-11-16

Decision date

2008-03-21

Days to decision

126 days

Decision code

APPR

Product code

NEK

Advisory committee

Orthopedic

Expedited review

No

Location

Memphis, TN

Statement

APPROVAL FOR THE FOLLOWING MODIFICATIONS TO THE PACKAGE INSERT: 1) INCLUSION OF WARNINGS RELATED TO LOCALIZED, TRANSIENT BONE RESORPTION AND POSSIBLE NERVE COMPRESSION DUE TO ECTOPIC BONE FORMATION PROMPTED BY A LABELING MODIFICATION REQUIRED BY THE EU AS A RESULT OF AN ANALYSIS OF REPORTED ADVERSE EVENTS; 2) INCLUSION OF CLINICAL AND ADVERSE EVENT DATA RESULTING FROM THE CLINICAL POST APPROVAL STUDY; 3) INCLUSION OF A WARNING RELATED TO ADVERSE EVENTS POTENTIALLY ASSOCIATED WITH OVER STUFFING T

510(k) clearances by this applicant