Infuse Bone Graft

FDA premarket approval P050053/S053 · decided 2022-02-18

Approval details

PMA number

P050053

Supplement

S053

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

Infuse Bone Graft

Generic name

Bone grafting material, dental, with biologic component

Applicant

Medtronic, Inc.

Date received

2020-07-29

Decision date

2022-02-18

Days to decision

569 days

Decision code

APPR

Product code

NPZ

Advisory committee

Dental

Expedited review

No

Location

Memphis, TN

Statement

Approval for extension of the expiration date from 18 to 24 months for three 1mg drug product lots manufactured at Hospira, Inc. (McPherson, Kansas) and seven 1mg drug product lots manufactured at Wyeth Farma S.A. (Algete, Spain) when stored at 5° and 30°C; addition of a 30 month timepoint to the long-term stability protocol studies performed at 30 ºC ± 2 ºC /75 ± 5% RH and 30 ºC ± 2 ºC /75 ± 5% RH; and discontinuation of testing at the 5°C long-term storage condition (current 5°C lots will cont

510(k) clearances by this applicant