INFUSE BONE GRAFT

FDA premarket approval P050053/S031 · decided 2013-12-06

Approval details

PMA number

P050053

Supplement

S031

Supplement type

Real-Time Process

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

INFUSE BONE GRAFT

Generic name

Bone grafting material, dental, with biologic component

Applicant

Medtronic, Inc.

Date received

2013-10-25

Decision date

2013-12-06

Days to decision

42 days

Decision code

APPR

Product code

NPZ

Advisory committee

Dental

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: AN ALTERNATIVE TO AUTOGENOUS BONE GRAFT FOR SINUS AUGMENTATIONS, AND FOR LOCALIZED ALVEOLAR RIDGE AUGMENTATIONS FOR DEFECTS ASSOCIATED WITH EXTRACTION SOCKETS.

510(k) clearances by this applicant