[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR878.4493]

[Page 401-402]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 878_GENERAL AND PLASTIC SURGERY DEVICES--Table of Contents
 
                       Subpart E_Surgical Devices
 
Sec. 878.4493  Absorbable poly(glycolide/l-lactide) surgical suture.

    (a) Identification. An absorbable poly(glycolide/l-lactide) surgical 
suture (PGL suture) is an absorbable sterile, flexible strand as 
prepared and synthesized from homopolymers of glycolide and copolymers 
made from 90 percent glycolide and 10 percent l-lactide, and is 
indicated for use in soft tissue approximation. A PGL suture meets 
United States Pharmacopeia (U.S.P.) requirements as described in the 
U.S.P. ``Monograph for Absorbable Surgical Sutures;'' it may be 
monofilament or multifilament (braided) in form; it may be uncoated or

[[Page 402]]

coated; and it may be undyed or dyed with an FDA-approved color 
additive. Also, the suture may be provided with or without a standard 
needle attached.
    (b) Classification. Class II (special controls). The special control 
for this device is FDA's ``Class II Special Controls Guidance Document: 
Surgical Sutures; Guidance for Industry and FDA.'' See Sec. 878.1(e) 
for the availability of this guidance document.

[56 FR 47151, Sept. 18, 1991, as amended at 68 FR 32984, June 3, 2003]