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Joni Morford, Communicore
714/721-8081
jmorford@communicore.com


JOHNSON & JOHNSON'S ADVANCED STERILIZATION PRODUCTS (ASP) RECEIVES FDA 510(k) CLEARANCE
FOR EXPANDED INSTRUMENT PROCESSING USES OF ITS STERRAD¨ 100 STERILIZATION SYSTEM

Sterilizer Now Cleared for Longer and Narrower Lumens, Offering Healthcare Facilities a 
Broad-Spectrum Sterilization System that is Fast, Safe, and Economical 


FOR IMMEDIATE RELEASE.....August 20, 1997.....Irvine, Calif.....Advanced Sterilization 
Products, a division of Johnson & Johnson Medical, Inc., today announced that it has received 
Food and Drug Administration 510(k) clearance for the expanded use of its STERRAD¨ 100 
Sterilization System in the sterilization of additional medical devices and surgical instruments.

The approval of this 510(k) demonstrates the STERRAD System's efficacy on difficult-to-
sterilize instruments used in the rapidly growing area of minimally invasive surgery.  The 
STERRAD 100 System is now cleared for the sterilization of surgical instruments containing 
longer and narrower lumens, such as those used in urologic, laparoscopic, and arthroscopic 
procedures, eliminating the need to separate surgical sets.  Specifically, instruments with single 
stainless steel lumens that have an inside diameter of 3 mm or larger and a length of 400 mm 
or shorter are now part of the long list of medical devices that can be sterilized in the 
STERRAD System.

According to Tralance O. Addy, Ph.D., worldwide president of Advanced Sterilization 
Products, the expanded instrument processing clearance represents ASP's success in 
responding to the marketplace's need for a broad-spectrum, low-temperature sterilization 
system that is fast, safe, and economical.  

"We are the only company to offer a sterilizer that meets those criteria," Addy said.  "In 
addition, many surgical instrument sets, which previously had to be divided for separate 
sterilization processing and then reassembled, can now be processed intact in the STERRAD 
100 System, saving healthcare facilities time and money."

The STERRAD Sterilization System is a general purpose medical sterilizer ideal for heat- and 
moisture-sensitive instruments based on a patented process involving the generation of low-
temperature hydrogen peroxide gas plasma.  Laboratory testing has proven the STERRAD 
System to be effective against a broad spectrum of microorganisms.  The System sterilizes in 
approximately 75 minutes, and it is safe for healthcare workers, patients, and the 
environment.  More than 2,000 STERRAD Sterilizers have been sold worldwide.

Advanced Sterilization Products (ASP), a division of Johnson & Johnson Medical, Inc., 
manufactures and markets innovative sterilization technologies and products that provide 
safe, effective, and economically sound solutions for the needs of healthcare providers.  The 
company is based in Irvine, Calif.


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