[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: 21CFR878.4494]

[Page 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. 878.4494  Absorbable poly(hydroxybutyrate) surgical suture 
produced by recombinant DNA technology.

    (a) Identification. An absorbable poly(hydroxybutyrate) surgical 
suture is an absorbable surgical suture made of material isolated from 
prokaryotic cells produced by recombinant deoxyribonucleic acid (DNA) 
technology. The device is intended for use in general soft tissue 
approximation and ligation.
    (b) Classification. Class II (special controls). The special control 
for this device is the FDA guidance document entitled ``Class II Special 
Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical 
Suture Produced by Recombinant DNA Technology.'' For the availability of 
this guidance document see Sec. 878.1(e).

[72 FR 43146, Aug. 3, 2007]