AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) FAMILY/FLOUR/SYRINGEAVITENE/CAST MICROFIBRILLAR COLLAGEN HEMOSTAT(MCH)

FDA premarket approval N17600/S026 · decided 2012-01-23

Approval details

PMA number

N17600

Supplement

S026

Supplement type

Special (Immediate Track)

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) FAMILY/FLOUR/SYRINGEAVITENE/CAST MICROFIBRILLAR COLLAGEN HEMOSTAT(MCH)

Generic name

Agent, absorbable hemostatic, collagen based

Applicant

Davol Inc., Sub. C. R. Bard, Inc.

Date received

2011-12-22

Decision date

2012-01-23

Days to decision

32 days

Decision code

APPR

Product code

LMF

Advisory committee

General, Plastic Surgery

Expedited review

No

Location

Warwick, RI

Statement

APPROVAL FOR THE ADDITION OF A PRECAUTIONS SECTION TO THE INSTRUCTIONS FOR USE FOR THE AVITENE FAMILY OF PRODUCTS. THE ADDITIONAL LANGUAGE IS AS FOLLOWS: "ANY EXCESS AVITENE MCH NOT REMOVED AT THE TIME OF SURGERY MAY EITHER PRESENT ITSELF AS A (RECURRING) MASS OR A (SPACE OCCUPYING) LESION OR IT MAY LEAD TO A FOREIGN BODY REACTION THAT MAY PRESENT WITH OR WITHOUT CLINICAL SIGNS AND SYMPTOMS AS A RECURRING MASS OR LESION OR POSTOPERATIVE ABSCESS FORMATION UPON IMAGING. IMAGING MAY INITIALLY NOT B

510(k) clearances by this applicant