INFUSE(R) BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE

FDA premarket approval P000058/S058 · decided 2015-01-27

Approval details

PMA number

P000058

Supplement

S058

Supplement type

Real-Time Process

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

INFUSE(R) 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

2014-10-29

Decision date

2015-01-27

Days to decision

90 days

Decision code

APPR

Product code

NEK

Advisory committee

Orthopedic

Expedited review

No

Location

Memphis, TN

Statement

APPROVAL FOR MODIFICATIONS TO THE PACKAGE INSERT AND PATIENT INFORMATIONBROCHURE (MODIFICATION OF THIS DOCUMENT WAS SUBSEQUENTLY WITHDRAWN) AS FOLLOWS:1) ADDITION OF WARNING AND PRECAUTION LANGUAGE RELATED TO DATA GENERATED FROM YOUR CERVICALSPINE STUDY; 2) CLARIFICATION TO THE POSTERIOR BONE FORMATION PRECAUTION; 3) REVISION TO THE RETROGRADE EJACULATION WARNING LANGUAGE; 4) ORGANIZATION OF THE WARNINGS INTO SIMILAR GROUPS OF ISSUES;5) REPLACEMENT OF ECTOPIC BONE FORMATION WITH HETEROTOPIC OSSI

510(k) clearances by this applicant