[Federal Register Volume 60, Number 61 (Thursday, March 30, 1995)]
[Notices]
[Pages 16480-16481]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-7744]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94M-0363]


Exogen<SUP>TM, Inc.; Premarket Approval of Sonic Accelerated 
Fracture Healing System (SAFHS<Register>); Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
that appeared in the Federal Register of November 9, 1994 (59 FR 
55847). The document announced the approval of the Exogen<SUP>TM, Inc., 
Sonic Accelerated Fracture Healing System (SAFHS<Register>). Some 
information was inadvertently omitted and incorrect approval dates were 
used. This document corrects those errors.

FOR FURTHER INFORMATION CONTACT: LaJuana D. Caldwell, Office of Policy 
(HF-27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-443-2994.
    In FR Doc. 94-27222, appearing on page 55847, in the Federal 
Register of November 9, 1994, the following corrections are made:
    1. On page 55847, in the third column, the ``SUMMARY'' section, 
beginning in the 5th line, ``September 13, 1994'' should read ``October 
5, 1994''; and in the ``SUPPLEMENTARY [[Page 16481]] INFORMATION'' 
section in, beginning in the 10th line, the words ``acceleration of the 
time to a healed fracture for fresh, closed, distal'' should read ``the 
treatment of fresh, closed, posteriorly displaced distal.''
    2. On page 55848, in the first column, in the first paragraph, in 
the 31st line, after the word ``indication'', the following paragraph 
is added:
    All other indications for the device will require additional 
data, and PMA supplements must be submitted for new indications. 
Furthermore, the applicant must conduct a study to gather additional 
information to validate some of the conclusions that were drawn from 
the PMA studies, based on a larger size.
    3. On the same page, in the first column, in the 38th line, after 
the word ``review'', the following paragraph is added:
    In accordance with the Panel's observation that differences 
exist in the rate of healing in different age groups, CDRH also 
directed the applicant to include a warning statement regarding the 
specific age range of the patients to be treated. CDRH concluded 
that based on the study's success criteria (e.g., both 
radiographically and clinically healed), the results of study did 
show a statistically significant difference in the time to a healed 
fracture in favor of the active device.
    4. On the same page, in the first column, in the 43d line, after 
the word ``panel'' the following phrase is added:
    ``additional statistical analysis of the patient data stratified 
by age and gender,''.
    5. On the same page, in the first full paragraph, in the first 
line, ``September 13, 1994'' should read ``October 5, 1994''.

    Dated: March 17, 1995.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 95-7744 Filed 3-30-95; 8:45 am]
BILLING CODE 4160-01-F