INFUSE BONE GRAFT-LT-CAGE LUMBAR TAPERED FUSION DEVICE

FDA premarket approval P000058/S010 · decided 2004-06-10

Approval details

PMA number

P000058

Supplement

S010

Supplement type

Real-Time Process

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

2004-05-20

Decision date

2004-06-10

Days to decision

21 days

Decision code

APPR

Product code

NEK

Advisory committee

Orthopedic

Expedited review

No

Location

Memphis, TN

Statement

APPROVAL FOR 1) AN INCREASE IN THE EXPIRATION DATE OF THE 4.2 AND 12 MG VIALED RHBMP-2 COMPONENT OF THE REFERENCED DEVICES FROM 36 TO 48 MONTHS; 2) AN INCREASE IN THE EXPIRATION DATE OF THE COMMERCIAL KIT COMPONENT FROM 24 TO 36 MONTHS; AND 3) THE PROTOCOL TO BE FOLLOWED FOR ALL FUTURE EXPIRATION DATE CHANGES.

510(k) clearances by this applicant