INFUSE BONE GRAFT

FDA premarket approval P000054/S040 · decided 2013-12-06

Approval details

PMA number

P000054

Supplement

S040

Supplement type

Real-Time Process

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

INFUSE BONE GRAFT

Generic name

Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction

Applicant

Medtronic Sofamor Danek USA, Inc.

Date received

2013-10-25

Decision date

2013-12-06

Days to decision

42 days

Decision code

APPR

Product code

MPW

Advisory committee

Orthopedic

Expedited review

No

Location

Memphis, TN

Statement

APPROVAL FOR EXTENSION OF THE RHBMP-2 DRUG SUBSTANCE EXPIRATION DATE FROM 60 TO 72 MONTHS USING THE APPROVED EXPIRATION DATE MODIFICATION PROTOCOL. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INFUSE®BONE GRAFT AND IS INDICATED FOR THE FOLLOWING: TREATING ACUTE, OPEN TIBIAL SHAFT FRACTURES THAT HAVE BEEN STABILIZED WITH IM NAIL FIXATION AFTER APPROPRIATE WOUND MANAGEMENT. INFUSE BONE GRAFT MUST BE APPLIED WITHIN 14 DAYS AFTER THE INITIAL FRACTURE. PROSPECTIVE PATIENTS SHOULD BE

510(k) clearances by this applicant